[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hematological-malignancy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hematological-malignancy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,40,67,93,130,152,173,198,218,240,266,293,317,339,369,390],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100447769","phase-1-phase-iii-study-of-cd5-car-engineered-il15-transduced-cord-blood-derived-nk-cells-in-conjunction-with-lymphodepleting-chemotherapy-for-the-management-of-relapsedrefractory-hematological-malignances-100447769",false,"NCT05110742","Phase I\u002FII Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed\u002FRefractory Hematological Malignances","Inclusion criteria\n\n1. Patients with hematological malignances with an expression of CD5 in the pre-enrollment tumor sample ≥ 30% measured by immunohistochemistry or flow cytometry.\n2. Patients must meet diseases specific eligibility criteria (see below)\n3. Patients should be at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy, with the last day of cytotoxic chemotherapy no later than Day-13. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least three days prior to administration of lymphodepleting chemotherapy, with the last day of tyrosine kinase inhibitors or other targeted therapies no later than Day-9.\n4. Localized radiotherapy to one or more disease sites are allowed prior the infusion provided that there are additional disease sites that are not irradiated.\n5. Karnofsky\u002FLansky Performance Scale \\> 50%.\n6. Adequate organ function:\n\n   1. Renal: Serum creatinine ≤ 2.0ULN or estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) ≥ 30 ml\u002Fmin\u002F1.73 m2.\n   2. Hepatic: ALT\u002FAST ≤ 3.0 x ULN or ≤ 5 x ULN if documented liver involvement with disease, Total bilirubin ≤ 2.0ULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be ≤ 3.0 mg\u002FdL. No history of liver cirrhosis.\n   3. Cardiac: Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no uncontrolled arrhythmias or symptomatic cardiac disease.\n   4. Pulmonary: No clinically significant lung involvement, per PI discretion, pleural effusion, baseline oxygen saturation \\> 92% on room air.\n7. Able to provide written informed consent.\n8. 12-80 years of age.\n9. English and non-English speaking patients are eligible.\n10. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.\n11. Signed consent to long-term follow-up protocol PA17-0483.\n12. Are willing and able to provide informed consent.\n13. Disease specific inclusion criteria\n\nA. T-cell non-Hodgkin's lymphoma and T-cell acute lymphoblastic leukemia\n\n1. Patients with history of T-lymphoid malignancies, defined as acute lymphoblastic leukemia (ALL\u002FT-LBL), Peripheral T-cell lymphoma (PTCL-NOS), MF\u002FSS, Hepatosplenic gamma\u002Fdelta NHL, AITL, ALCL, or other subtypes of T cell NHL, T-PLL, Mixed phenotypic leukemia (MPAL) with CD5 expression who have received at least 2 lines of standard chemo-immunotherapy or targeted therapy and have measurable persistent disease. For T-ALL active disease defined as (\\>5% of blasts or positive MRD at a level of \\>0.1% measured by multiparameter flow cytometry).\n2. Patients with history of T-lymphoid malignancies as defined above with relapsed disease following standard therapy or a stem cell transplant.\n\nB. Chronic lymphocytic leukemia (CLL) Chronic lymphocytic leukemia (CLL) small lymphocytic lymphoma (SLL), Richter's transformation of CLL or SLL who have received at least 2 lines of standard therapy or targeted therapy to include chemoimmunotherapy e.g. FCR, BTK inhibitors and a BCL-2 inhibitor and have persistent disease.\n\nC. Mantle cell lymphoma Relapsed or refractory mantle cell lymphoma after 2 lines of standard chemoimmunotherapy including a BTKi.\n\nExclusion criteria:\n\n1. Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.\n2. Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.\n3. Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.\n4. Active hepatitis B or C.\n5. HIV with detectable viral load.\n6. Presence of active neurological disorder(s).\n7. Active autoimmune disease within 12 months of enrollment\n8. Active cerebral or meningeal involvement by the malignancy\n9. Active (defined as requiring therapy) acute or chronic GVHD.\n10. Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.\n11. Presence of any other serious medical condition that may endanger the patient at investigator criteria.\n12. Major surgery \\\u003C4 weeks prior to first dose of study drug\n13. Allogeneic SCT or DLI \\\u003C12 weeks prior to first dose of study drug. Recipients of an allogeneic SCT patients should have discontinued all forms of immunosuppression at least 8 weeks prior enrollment in the study.\n14. Concomitant use of other investigational agents.\n15. Concomitant use of other anti-cancer agents.\n16. Patients receiving systemic steroid therapy at time of NK cell infusion (physiological substitutive doses are allowed) or have received ATG or lymphocyte immune globulin within 14 days or alemtuzumab within 3 months of enrollment.\n17. Patients receiving immunosuppressive therapy.\n18. Patients with diminished mental capacity will not be enrolled on the study.","ALL","18 Years",{"count":18,"type":19},64,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","To determine the safety, efficacy and optimal cell dose of CAR 5\u002FIL15-transduced CB-NK cells in patients with relapsed\u002Frefractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases.",[26],"Hematological Malignancy","RECRUITING","2026-08-18",{"date":30,"type":31},"2026-08-20","ACTUAL",{"date":33,"type":31},"2024-04-22",{"date":35,"type":19},"2030-12-31",{"name":37,"class":38},"M.D. Anderson Cancer Center","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":49,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100648730","phase-1-study-to-evaluate-the-safety-and-effectiveness-of-withaferin-a-as-a-treatment-to-prevent-gvhd-in-transplant-patients-100648730","NCT07724873","Study to Evaluate the Safety and Effectiveness of Withaferin A as a Treatment to Prevent GvHD in Transplant Patients","A Phase I\u002FII Trial to Assess Safety and Activity of Standardized Withaferin A as GvHD Prophylaxis in Patients Undergoing Matched Related Donor Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n1. ECOG performance score of 0 or 1\n2. Adequate liver function (Total serum bilirubin \\\u003C twice upper normal limit or Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 3-fold higher than laboratory upper normal limits)\n3. Adequate renal function (creatinine clearance \\> 50 ml\u002Fmin)\n4. Adequate cardiac function (LVEF\\>40%)\n5. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.\n6. Signed, written informed consent\n\nExclusion Criteria: -\n\n1. Known hypersensitivity or contraindications against Withaferin-A.\n2. Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection.\n3. Any medical or psychiatric illness which precludes the participant from giving informed consent\n4. Pregnancy, lactation, or inadequate contraception.",{"count":48,"type":19},54,[22,23],"What is acute Graft versus host disease (aGvHD)? GvHD is a complication that can occur after an allogeneic stem cell transplant resulting in damage to some organs. The death rate of GvHD patients is 15-40%. In GvHD, the donated peripheral blood stem cells or bone marrow view the recipient's body as foreign, and the donated cells\u002Fbone marrow harm the body. aGvHD usually develops in skin, liver or gastrointestinal tract, and symptoms might appear within few weeks after transplant. Symptoms of acute GvHD are observed as skin rash or reddened areas on the skin, yellow discoloration of the skin and\u002For eyes, and abnormal blood test results, nausea, vomiting, diarrhea, or abdominal cramping.\n\nWhat is the current prevention used for GvHD? To prevent development of GvHD many standard drugs like cyclosporine (CSA), tacrolimus (TAC), methotrexate (MTX), mycophenolate mofetil (MMF), rapamycin and cyclophosphamide are given.\n\nWhat is standardized Withaferin-A (SWA)? Withaferin-A (WA) is the main active component of Withania somnifera (Ashwagandha). It has been shown in many studies to have properties of healing and immune-modulation (improving the immune system). Studies have been done in our Clinical Pharmacology Laboratory that have shown a significant beneficial effect of this drug, when added to the standard drugs used for prophylaxis of GvHD, on reducing the risk of acute GvHD. The drug has also been tested and proven to be very safe in humans.\n\nWhat is the rationale of this trial? As has been described earlier, GvHD is a difficult complication of allogeneic stem cell transplant which can lead to increased hospital stay and deaths post-transplant. The standard drugs for prevention of GvHD are cyclosporine (CSA), tacrolimus (TAC), methotrexate (MTX), mycophenolate mofetil (MMF), rapamycin and cyclophosphamide. These drugs also have some side effects during the course of transplant. This points out the need for new preventive drugs that are safe and effective.\n\nSWA is an oral formulation of WA which seems to be beneficial in the early studies done in the Clinical Pharmacology Laboratory, ACTREC. SWA has also been found to be safe at very high doses.\n\nSWA will be given along with the standard drugs given to prevent GvHD. Despite of consuming these drugs, about 40 - 60% patients still develop GvHD. The investigators aim to add SWA to these standard drugs during transplant to reduce significant aGvHD.\n\nHow will SWA be given? Participants who agree to participate in this trial and are found to be eligible will be given SWA as a capsule at a dose of 500 mg\u002Fday (2 capsules of 250 mg) to 3000 mg\u002Fday (6 capsules of 250 mg) as per the dose level allotted to the Patient. The drug will be given for a total duration 90 days starting from Day +1 of transplant. All other standard treatments which are part of a transplant procedure will be carried out without any change.\n\nParticipants will be monitored clinically for any adverse events and followed up as per standard protocols post-transplant.\n\nWhat additional tests will be carried out? Additional blood sampling to study the levels of the drug WA blood samples will be collected at 0, 1, 2, 4, 8 hours on the day of start of SWA (Day +1) and Day +7. Checking immune cell profile and cytokines (which are markers of - immunity levels) will be done at Day+30, Day +90, Day+180, Day+365 from the start of SWA which is also the part of routine care. Blood sample of 5 ml will also be taken at Day 0, Day +14, Day +30, Day +60 and Day +90 after start of drug to see level of some special protein called JAK2 STAT3 protein.\n\nWhat are the risks involved in participation? According to available literature and information, SWA is a safe and well tolerated drug. In a phase 1 study, Standardized Withaferin-A was administered to Patients with advanced stage osteosarcoma. The drug was well tolerated by Patient up to a dose of 4800 mg. No severe side effects were observed. Increase in liver enzymes and skin rash were the most common side effects. Other side effects included fatigue, fever, swelling, and diarrhea.\n\nWhat is the possible impact of this trial? If indeed SWA works and prevents GvHD effectively then this could be a breakthrough in treatment. It would help many Pateints to prevent GvHD post allogeneic stem cell transplant and would be a safe, easily available, inexpensive and oral drug for the same. This possibly could benefit and help future Patients who undergo bone marrow transplant (BMT) to have better chances of survival and reduce their financial burden.",[52,53,26],"Hematopoietic Stem Cell Transplant (HSCT)","GVHD - Graft-Versus-Host Disease",[55,56],"Standardized Withaferin A","Matched related donor Hematopoietic stem cell transplant","2026-07-20",{"date":59,"type":31},"2026-07-24",{"date":61,"type":31},"2025-01-28",{"date":63,"type":19},"2029-12-03",{"name":65,"class":38},"Tata Memorial Centre",2,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":15,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":20,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":39},"100647328","phase-2-study-of-standardized-withaferin-a-for-the-treatment-of-steroid-refractory-acute-graft-versus-host-disease-100647328","NCT07708987","Study of Standardized Withaferin-A for the Treatment of Steroid Refractory Acute Graft Versus Host Disease.","A Phase II Clinical Trial of Standardized Withaferin-A for the Treatment of Steroid Refractory Acute Graft Versus Host Disease","Withaferin_A","Inclusion Criteria:\n\n* Patients age ≥ 12 years with a hematological malignancy who have undergone allogeneic stem cell transplant with matched related donor (MRD), Haploidentical (Haplo) donor or matched unrelated donor (MUD)\n* Evidence of myeloid engraftment (eg, absolute neutrophil count ≥0.5 × 109 \u002FL for 3 consecutive days)\n* ECOG performance score of 0 or 1\n* Patients with steroid-refractory aGvHD, defined as any of the following:\n* Patients with progressive GvHD (ie, increase in stage in any organ system or any new organ involvement) after 3 days of primary treatment with methylprednisolone ≥2 mg\u002Fkg\u002Fd (or equivalent)\n* Patients with GvHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 7 days of primary treatment with methylprednisolone ≥2 mg\u002Fkg\u002Fd (or equivalent)\n* Patients who previously began corticosteroid therapy at a lower dose (≥1 mg\u002Fkg\u002Fd methylprednisolone) for treatment of skin GvHD or skin GvHD accompanied by upper gut GvHD but develop new GvHD in another organ system\n* Patients who cannot tolerate a corticosteroid taper, that is, begin corticosteroids at 2.0 mg\u002Fkg\u002Fd, demonstrate response, but progress before a 50% decrease from the initial starting dose of corticosteroids is achieved\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindications against Withaferin-A.\n* Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection.\n* Any medical or psychiatric illness which precludes the participant from giving informed consent.","12 Years","65 Years",{"count":78,"type":19},34,[23],"Study Design Prospective, single center, single arm, Phase II study.\n\nResearch aims and objectives Aim:\n\nTo evaluate the efficacy and safety of standardized Withaferin A in steroid refractory acute GvHD in patients post allogeneic stem cell transplantation\n\nPrimary Objective:\n\nTo evaluate the objective Response Rate (ORR) at Day 28 from the start of SWA defined as the proportion of patients achieving Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR).\n\nMethodology\n\nTreatment plan and Interventions Administration of study treatment Name of the intervention: Standardized WA (standardized root extract of Withania somnifera. This will be provided free of cost to the trial patients.\n\nFormulation: The standardized root extract of W. somnifera contains 5% of WA w\u002Fw. SWA is available as a 500 mg capsule (AshwaMAX) that contains 25 mg of WA.\n\nRoute of administration: Per-oral (P\u002FO) Dose schedule: The dose of SWA is 1500mg\u002Fday. It will be administered as 3 capsules of 500 mg once a day.\n\nDuration of treatment:\n\n* Every patient will receive treatment for at least 12 weeks followed by a taper as per physician's discretion. WA can be tapered after 12 weeks if the patient has achieved CR or VGPR and has discontinued corticosteroids for at least 4 weeks.\n* Dose adjustments\u002Fmodifications: If the patient experiences any grade ≥3 toxicities related to SWA, further administration of SWA will be withheld immediately. Once the severity of the adverse event reduces to grade ≤1, the study agent will be rechallenged with 25% dose reduction. The same strategy will be adopted for successive grade ≥3 toxicities. If the drug is not tolerated at 25% of original dose (100 mg), no further rechallenge will be attempted.\n* Corticosteroid tapering will be done as per the treating physician's discretion and clinical condition of the patient.",[26,53,82],"Steriod Refractory",[84],"Withaferin A","2026-07-11",{"date":87,"type":31},"2026-07-16",{"date":89,"type":31},"2023-09-23",{"date":91,"type":19},"2028-09-25",{"name":65,"class":38},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":15,"minAge":101,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":20,"phases":104,"briefSummary":106,"conditions":107,"keywords":115,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":39},"100615412","halt-aging-in-survivors-of-blood-cancers-100615412","NCT07292272","Halt Aging in Survivors of Blood Cancers","Halt Aging in Survivors of Blood Cancers: the HALTAging-1 Study","HALTAging-1","Inclusion Criteria:\n\n1. Age ≥50 years\n2. A history of hematological malignancy\n3. Participants must be able to and willingly give informed consent\n\nExclusion Criteria:\n\n1. Patients receiving intensive induction or consolidation chemotherapy. Maintenance chemotherapy, or lower-intensity chemotherapy for an indolent hematological malignancy is allowed.\n2. Neurodegenerative disease (e.g. Alzheimer's dementia), stroke, or uncontrolled psychotic disorders (e.g. schizophrenia or bipolar disorder) in the past 3 months if those disorders are considered significant enough to impair participation in the study.\n3. Illnesses such as clinical evidence of decompensated heart failure, unstable angina, or orthopedic or neuromuscular disorders that could limit safe participation in aerobic exercise.\n4. Cardiopulmonary exercise test results that preclude safe exercise (e.g., life-threatening arrhythmia, balance difficulties, peak VO2 \\\u003C10 ml\u002Fkg\u002Fmin).\n5. Estimated life expectancy of less than 6 months (that precludes assessment of study primary endpoint).\n6. Self-reported pregnancy or the possibility of pregnancy.\n7. Participants who do not plan to follow up at the participating center.","50 Years",{"count":103,"type":19},180,[105],"NA","Older survivors of blood cancer are at a high risk of accelerated biological aging, which increases their risk of developing multiple aging-related conditions. Whereas physical exercise can improve overall health, older cancer survivors do not meet the recommended physical activity, highlighting the need to develop behavioral interventions to increase adherence. Several other knowledge gaps exist to implement exercise interventions in older survivors of blood cancer; the dose and duration of exercise necessary to slow biological aging in older blood cancer survivors remain unknown. To bridge these gaps in knowledge, we have designed a Phase 2 randomized control trial to test the effects of behavioral and exercise interventions on various outcomes.",[26,108,109,110,111,112,113,114],"Leukemia","Lymphoid Leukemia","Multiple Myeloma","Myeloid Leukemia","Monocytic Leukemia","Non-hodgkin Lymphoma","Other Hematologic Condition",[116,108,109,110,111,112,113,114,117,118,119,120],"Hodgkin Lymphoma","Epigenetic clock","Biological aging","Quality of life","Blood cancer survivors","2026-06-29",{"date":123,"type":31},"2026-07-01",{"date":125,"type":31},"2026-04-09",{"date":127,"type":19},"2033-03-25",{"name":129,"class":38},"University of Nebraska",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":20,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":39},"100480585","phase-2-prospective-evaluation-of-xerava-prophylaxis-in-hematological-malignancy-patients-with-prolonged-neutropenia-100480585","NCT05537896","Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia","Prospective Evaluation of Xerava™ (Eravacycline) Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia","Inclusion Criteria:\n\n* All patients receiving induction chemotherapy for treatment of acute leukemia or receiving preparative regimen for HSCT\n* Patient must provide informed consent.\n* Bilirubin ≤ 3 x the ULN and AST\u002FALT ≤ 5 x ULN\n\nExclusion Criteria:\n\n* Uncontrolled bacterial, viral or fungal infection at the time of study enrollment.\n* Urinary tract infection receiving active treatment\n* Acute pancreatitis (not necessary to work-up unless symptomatic)\n* History of known hypersensitivity to eravacycline, tetracycline, doxycycline, minocycline, tigecycline, sarecycline, oxytetracycline, or omadacycline\n* Pseudomonas infection within 30 days prior to study enrollment\n* Receiving strong inhibitors or inducers of cytochrome P450 3A4 will be excluded from the study (see Appendix B for complete list of medications)\n* Pregnant or lactating women",{"count":138,"type":19},55,[23],"Antibacterial prophylaxis is recommended in patients at high risk of infection, specifically patients undergoing acute leukemia induction therapy or hematopoietic stem cell transplant (HSCT) who are expected to have profound neutropenia (ANC\\\u003C100 neutrophils\u002Fmilliliter) for more than seven days. Xerava™ (eravacycline) has a broad spectrum of activity including many multi-drug resistant strains of bacteria. It is not an agent used for treatment of febrile neutropenia, making eravacycline a very attractive alternative to consider in this prophylactic setting. Eravacycline has activity against MRSA, VRE, and Clostridioides difficile, all of which are common problems in this patient population. It also covers the majority of enteric gram-negative pathogens while also producing satisfactory tissue penetration and adequate plasma concentrations, which has classically been a concern with prior agents. Eravacycline has activity against coagulase-negative staphylococcus, which is a common catheter-related infection in leukemia and HSCT patients. The primary objective will be report the incidence of breakthrough infections during eravacycline prophylaxis for hematologic malignancy patients with prolonged neutropenia.",[26,142],"Neutropenia","2026-04-12",{"date":145,"type":31},"2026-04-16",{"date":147,"type":31},"2024-02-19",{"date":149,"type":19},"2028-02",{"name":151,"class":38},"West Virginia University",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":76,"enrollmentInfo":159,"targetDuration":4,"studyType":20,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":39},"100351019","phase-2-hla-haploidentical-peripheral-blood-stem-cell-transplantation-with-post-transplant-cyclophosphamide-and-bortezomib-100351019","NCT03850366","HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib","HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib Following Fludarbine\u002FMelphalan\u002FTotal Body Irradiation Conditioning Regimen","Inclusion Criteria:\n\n* 18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (\\\u003C\u002F= 7\u002F8 allele match at the A, B, C, DR loci with a minimum match of 5\u002F10 is required) is identified\n* Candidate for stem cell transplant in a malignant hematological condition\n* Karnofsky Performance Scale 0-1\n* Available donor able to undergo a Peripheral blood stem cells collection\n* Bilirubin \\\u003C\u002F= 1.5 mg\u002Fdl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\\u003C\u002F= 200 IU\u002Fml for adults.\n* Serum creatinine clearance \\>\u002F=60 ml\u002Fmin (calculated with Cockroft-Gault formula)\n* Diffusing capacity for carbon monoxide (DLCO) \\>\u002F= 45% predicted corrected for hemoglobin.\n* Left ventricle ejection fraction \\> 40%.\n* Patient or patient's legal representative, parent(s) or guardian should provide written informed consent.\n\nExclusion Criteria:\n\n* Adult who has a suitable related or unrelated donor or cord units available for transplant. Suitable donors include 8\u002F8 (HLA-A,B,C and DR, with all loci high-resolution typing) or 7\u002F8 related or unrelated donor available within 42 days of search initiation\n* HIV positive; active hepatitis B or C\n* Patients with active uncontrolled infections.\n* Liver cirrhosis\n* Uncontrolled central nervous system involvement by tumor cells\n* Positive Beta Human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.\n* Inability to comply with medical therapy or follow-up",{"count":160,"type":19},15,[23],"Now haplo stem cell transplant using bone marrow or peripheral blood is becoming more feasible with better regimens to prevent graft versus host disease (GVHD) like post transplant cyclophosphamide , tacrolimus, mycophenolate . Recently Bortezomib has also been shown to inhibit dendritic cells maturation and function and possesses a number of other favorable immunomodulatory effect that can prevent GVHD and help enhance immune reconstitution. this study is to assess the engraftment rate in patients with hematologic malignancies who need allogeneic stem cell transplant but do not have a suitable matched related or unrelated stem cell donor and will get T-cell replete HLA-Haploidentical allogeneic peripheral stem cell transplantation using post transplant Cyclophosphamide and bortezomib",[26],"2026-02-23",{"date":166,"type":31},"2026-02-24",{"date":168,"type":31},"2016-03-08",{"date":170,"type":19},"2028-01-01",{"name":172,"class":38},"Henry Ford Health System",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":180,"targetDuration":182,"studyType":183,"phases":4,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":39},"100524256","a-pilot-prospective-clinical-trial-using-remote-monitoring-for-cancer-patients-undergoing-outpatient-chemotherapy-100524256","NCT06106360","A Pilot Prospective Clinical Trial Using Remote Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy","A Pilot Prospective Clinical Trial Using Remote Patient Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy","Inclusion Criteria:\n\n* Planned to be treated with a new cytotoxic chemotherapy or chemoimmunotherapy regimen for a solid tumor or malignant hematology condition for at least 4 months\n* ECOG performance status of 0-2\n* Age of 18 or older patient with any solid tumor or hematologic malignancy\n* English or Spanish speaker\n* Own an Apple iPhone\n* Capacity and willingness to provide informed consent\n\nExclusion Criteria:\n\n* Patients undergoing concurrent radiation since they will be seen on a daily basis by clinic care teams and are not likely to benefit from active remote patient monitoring\n* Patients unwilling or unable to comply with the protocol, including wearing the Apple Watch (including recharging daily) and answering queries on the Locus Health iPhone application per the protocol and study group cadence\n* Any condition for which in the Investigator's opinion would limit compliance with study requirements",{"count":181,"type":19},100,"120 Days","OBSERVATIONAL","A pilot study using remote monitoring technology developed by Locus Health in cancer patients undergoing chemotherapy treatment.",[186,26],"Solid Tumor",[188],"Wearable Electronic Devices","2025-12-04",{"date":191,"type":31},"2025-12-08",{"date":193,"type":31},"2023-10-26",{"date":195,"type":19},"2026-06-26",{"name":197,"class":38},"Inova Health Care Services",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":39},"100427087","membrane-target-detection-for-leukemia-treatment-100427087","NCT04841447","Membrane Target Detection for Leukemia Treatment","Tumor Cell and DNA Detection in the Peripheral Blood of Patients With Hematological Malignancy","Inclusion Criteria:\n\n* All hematological malignancy patients.\n* Must be 18 years old.\n\nExclusion Criteria:\n\n* Participants with impaired decision-making capacities;\n* Pregnant women or fetuses;\n* Children (under 18 in Missouri, also dependent on State law);\n* Non-viable neonates or neonates of uncertain viability (neonates=newborns);\n* Non-English-speaking subjects;\n* Prisoners.",{"count":206,"type":19},50,"Acute myeloid leukemia (AML) accounts for more than 40% of leukemia mortality in the United States. Each year around ten thousand people die from the disease, most within a few years of diagnosis. Despite advances in our understanding of the disease, few improvements in the therapy of AML have been made. Collecting specimens from the blood and bone marrow will increase understanding of the effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibitors on human AML-SCP to develop individualized therapies. We also found DPP4 is highly expressed in other hematological malignancies in our mouse model, thus we would like to use human samples to investigate the role of DPP4 in hematological malignancy development and the mechanism underlying, especially to deeply understand the role of DDP4 in leukemia.",[26],"2025-12-03",{"date":211,"type":31},"2025-12-10",{"date":213,"type":31},"2020-03-20",{"date":215,"type":19},"2027-03-20",{"name":217,"class":38},"University of Missouri-Columbia",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":20,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":230,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":39},"100594351","micro-assays-for-hematology-malignancies-antibody-treatment-100594351","NCT07018310","Micro Assays for HemATology Malignancies Antibody Treatment","MAHATMAt","Inclusion Criteria:\n\n* Male or Female over 18 years of age\n* Patient with a hematological malignancy likely to benefit from immunotherapy (in any form; at the discretion of the referring physician)\n* Before the start of 1st-line treatment, successive lines or before autograft (chemotherapy-free for at least 4 weeks in these cases).\n* Patient has received information about the study and has not expressed opposition.\n* Patient who is a beneficiary or entitled beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Person in a period of exclusion from another research protocol at the time the non-opposition is signed.\n* Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code, i.e. :\n\n  * Persons deprived of their liberty by judicial or administrative decision\n  * Persons subject to psychiatric monitoring under articles L3112-1 and L3113-1 who are not covered by the provisions of article L1121-8\n  * Minors\n  * Adults under legal protection or unable to express their consent.\n* A person who cannot read and understand the French language well enough to be able to consent to take part in research.",{"count":226,"type":19},166,[105],"Hematological malignancy is a disease of the blood. In some cases, this pathology requires therapeutic management, which is not necessarily the case for you. Nevertheless, to improve the management of patients who need it, we are conducting research to assess the state of your immune system. Indeed, the role of the immune system is not limited to controlling infections, but is also important in controlling the proliferation of cancer cells, in hematology as in other types of cancer. Your immune system can play a spontaneous anti-tumor control role, but some so-called \"immunotherapy\" treatments aim to destroy cancer cells by stimulating the immune system, restoring its capabilities, and directing the immune response against tumor cells. For this immunotherapy treatment to be effective, since it uses your own immune cells (in most cases), these cells must be in a state to respond and be able to destroy the tumor. It is this ability to activate immune cells that is tested in this research protocol, using a simple test that could in future be used in routine clinical practice. But to understand why these immune cells don't work, we will also have to carry out genetic tests to analyze the various molecules that could interfere with the immune response, and try to inhibit the molecules that prevent the immune response.",[26],"NOT_YET_RECRUITING","2025-11-17",{"date":233,"type":31},"2025-11-20",{"date":235,"type":19},"2026-01",{"date":237,"type":19},"2029-01",{"name":239,"class":38},"Assistance Publique Hopitaux De Marseille",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":20,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100250123","bergonie-institut-profiling--fighting-cancer-by-matching-molecular-alterations-and-drugs-in-early-phase-trials-100250123","NCT02534649","Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials","BIP","Inclusion Criteria:\n\n1. Age ≥ 18 years,\n2. Histology: solid malignant tumor or hematological malignancy,\n3. Deleted MSA9\n4. Deleted MSA9,\n5. Deleted MSA9,\n6. Deleted MSA9,\n7. Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code),\n8. Voluntary signed and dated written informed consent prior to any study specific procedure.\n\nExclusion Criteria:\n\n1. Deleted MSA9\n2. Deleted MSA9\n3. Deleted MSA9\n4. Deleted MSA9\n5. Deleted MSA9\n6. Deleted MSA9\n7. Deleted MSA9\n8. Deleted MSA9\n9. Individuals deprived of liberty or placed under guardianship\n10. Pregnant or breast feeding women,\n11. Previous enrolment in the present study.",{"count":248,"type":19},10000,[105],"This is a biology driven, monocentric study designed to identify actionable molecular alterations in cancer patients with advanced disease.\n\nIn this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling.\n\nPatients included in the BIP study and for whom a targetable genomic alteration had been identified might be subsequently included in an early phase trials running at Institut Bergonie or another French hospital.",[186,26],[253,254,255],"Molecular profiling","Genomic alteration","Advanced cancer","2025-10-01",{"date":258,"type":31},"2025-10-02",{"date":260,"type":31},"2015-12",{"date":262,"type":19},"2029-12",{"name":264,"class":38},"Institut Bergonié",7,{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":275,"conditions":276,"keywords":278,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":265},"100498285","a-study-for-participants-previously-treated-with-century-therapeutics-cellular-therapy-product-100498285","NCT05768269","A Study for Participants Previously Treated With Century Therapeutics Cellular Therapy Product","A Long-Term Follow-up Study for Subjects Previously Treated With A Century Therapeutics Cellular Therapy Product","Inclusion Criteria:\n\n* Participant has provided written informed consent prior to any long-term follow-up (LTFU) study-specific procedures.\n* Participants received at least one treatment with a cellular therapy product in an eligible index trial.\n* Participant was withdrawn, early discontinued or completed an eligible index trial.\n* Participant is willing and able to comply with scheduled visits, study plan, and other study procedures.\n\nExclusion Criteria:\n\n-This study has no exclusion criteria.",{"count":274,"type":19},375,"This study is designed to collect long-term safety and survival data from participants previously treated in an eligible Century-sponsored index trial. This is an observational study, and the elements of the study design allow for important follow-up for safety, survival, and the continued evaluation of any late adverse events (AEs) that may appear after treatment with such cellular products. Additionally, collection of persistence data from participants will support the identification of any long-term risks or late AEs that may be causally related to treatment with such cellular products.",[26,277],"Solid Tumor Malignancy",[279,280,281,282],"Century Therapeutics","Cellular Therapy","Cell therapy","Malignancy","2025-06-24",{"date":285,"type":31},"2025-06-25",{"date":287,"type":31},"2024-04-29",{"date":289,"type":19},"2040-03",{"name":291,"class":292},"Century Therapeutics, Inc.","INDUSTRY",{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":300,"enrollmentInfo":301,"targetDuration":4,"studyType":20,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":39},"100458923","cxcr4-targeted-petct-imaging-in-hematological-malignancies-100458923","NCT05255926","CXCR4-targeted PET\u002FCT Imaging in Hematological Malignancies","An Exploratory, Open-Label, Single Center Study of CXCR4-targeted PET\u002FCT Imaging for Evaluation of Hematological Malignancies","Inclusion Criteria:\n\n1. Volunteer to participate and sign an informed consent form;\n2. 18 ≤ Age ≤ 90 years;\n3. Patients with highly suspected, or newly diagnosed, or relapsed hematological malignancies;\n4. Willing and able to follow schedule visits, treatment plans and laboratory tests.\n\nExclusion Criteria:\n\n1. pregnancy or breastfeeding;\n2. Allergic to CXCR4-targeted tracers or excipients;\n3. Fasting blood glucose level exceeded 11.0 mmol\u002FL prior to injection of 18F-FDG;\n4. Those who cannot complete PET\u002FCT scan, including inability to keep supine, claustrophobia, radiation phobia, etc.;\n5. Researchers think it is inappropriate to participate in this clinical trial for patients with poor compliance or other unsuitable factors.","90 Years",{"count":302,"type":19},300,[105],"Hematological malignancies continue to pose significant clinical challenges due to their high incidence, heterogeneous biology, and substantial mortality. Although 18F-FDG PET\u002FCT remains the most commonly used molecular imaging modality, its limited specificity can result in false-positive or false-negative findings, especially in indolent or low-metabolism subtypes, thereby hampering accurate diagnosis, staging, and therapeutic evaluation. C-X-C chemokine receptor type 4 (CXCR4) is frequently overexpressed in a broad spectrum of hematologic malignancies and correlates with aggressive disease and unfavorable outcomes. CXCR4-targeted molecular imaging using \\^68Ga-pentixafor PET\u002FCT has shown promise for improved disease characterization. This prospective study aims to systematically compare 68Ga-pentixafor PET\u002FCT with 18F-FDG PET\u002FCT in terms of diagnostic performance, staging accuracy, risk stratification, and prognostic relevance in patients with hematological malignancies. Furthermore, the study will incorporate artificial intelligence-based image analysis to enhance lesion detection, automate quantitative assessments, and support personalized clinical decision-making.",[306,307,26],"CXCR4","PET\u002FCT","2025-06-22",{"date":310,"type":31},"2025-06-26",{"date":312,"type":31},"2022-03-01",{"date":314,"type":19},"2026-12-31",{"name":316,"class":38},"Zhongnan Hospital",{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":20,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":338},"100502915","phase-1-first-in-human-study-of-ot-a201-in-patients-with-selected-hematological-malignancies-and-solid-tumors-100502915","NCT05828459","First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors","A First-in-human, Dose-escalation Followed by Expansion Study to Assess the Safety and Preliminary Efficacy of a Bispecific Antibody OT-A201 as Monotherapy and in Combination Therapy in Patients With Selected Hematological Malignancies and Solid Tumors","Main Inclusion Criteria:\n\n* Histologically or cytologically confirmed relapsed\u002Frefractory hematological malignancy or advanced\u002Fmetastatic solid cancer\n* Measurable disease\n* Have had all available therapeutic standards for their disease\n* Willingness to undergo baseline biopsy\u002Fbone marrow aspiration in case biopsy was not collected after completion of the most recent prior therapy\n* ECOG performance status ≤ 1\n* Life expectancy \\> 3 months as assessed by the investigator\n* Acceptable clinical lab results\n\nMain Exclusion Criteria:\n\n* Systemic steroids at a daily dose of \\> 10 mg of prednisone or equivalent within 28 days before study treatment. Transient use of steroids for other medical condition may be allowed\n* Ongoing immune-related adverse events irAEs and or AEs ≥ grade 2 from previous therapies not resolved except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy\n* Within 4 weeks of major surgery\n* Documented history of active autoimmune disorder requiring systemic immunosuppressive therapy within the last 12 months\n* Prior solid organ transplant\n* Primary or secondary immune deficiency\n* Active and uncontrolled infection requiring intravenous antibiotic or antiviral treatment\n* Seropositive (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)\n* Clinically significant disease",{"count":325,"type":19},150,[22],"This phase 1 study is aimed at establishing the safety basis of OT-A201 in the treatment of hematological malignancies and solid tumors. In the dose of escalation part it is to characterize the overall safety and tolerability profile and determine the recommended dose(s) of OT-A201 as monotherapy, and in various combination regimens. Preliminary information about anti-cancer activity will be further explored in the expansion part of the study.",[26,186],"2025-03-17",{"date":331,"type":31},"2025-03-20",{"date":333,"type":31},"2023-07-10",{"date":335,"type":19},"2027-07",{"name":337,"class":292},"Onward Therapeutics",4,{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":345,"enrollmentInfo":346,"targetDuration":4,"studyType":20,"phases":348,"briefSummary":349,"conditions":350,"keywords":352,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":39},"100574394","phase-1-safety-and-efficacy-of-fourth-generation-car-t-in-the-treatment-of-hematologic-malignancies-100574394","NCT06758713","Safety and Efficacy of Fourth-Generation CAR-T in the Treatment of Hematologic Malignancies","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1\\. Voluntarily participate in this clinical study and sign the informed consent form; 2. 18 to 75 years old (including cut-off value), Male and female;; 3. Expected survival of at least 3 months; 4.1 CD19-positive B lymphocyte-derived hematologic malignancies; 4.2 Multiple myeloma patients; 4.3 Non-B cell-derived hematologic malignancies patients with CD7 or other target molecules; 5. The clinical trial values during the screening period meet the following criteria:\n\n1. White blood cell count ≥ 3.0 × 10e9\u002FL; Absolute neutrophil ≥ 1.0 × 10e9\u002FL; Lymphocyte count ≥ 0.5 × 10e9\u002FL. (The growth factor support is allowed, but growth factor must not have been received within 7 days prior to laboratory testing);\n2. Platelet count ≥ 50 × 10e9\u002FL (No blood transfusion support within 7 days prior to laboratory tests.); Note: Patients with leukemia, multiple myeloma, and lymphoma are not subject to the above blood picture requirements;\n3. Biochemical indicators Serum total bilirubin (TBIL) ≤ 2.5 ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN, or 5 ULN if liver dysfunction is primarily due to tumor invasion); 6. Cardiac function: Subjects must have good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 55%; 7. Lung condition: Subjects are not serious infections such as severe pneumonia; 8. ECOG activity status score: 0-2 points; 9. Female subjects must use effective contraception (such as oral prescription contraceptives, injectable contraceptives, intrauterine devices, double blockade, contraceptive patches, male partner sterilization) throughout the study period; Must have a negative serum or urine pregnancy test result at screening and throughout the study.\n\nExclusion Criteria:\n\nAny one of the following conditions cannot be selected as a subject:\n\n1. Having received CAR-T therapy targeting the same molecule;\n2. Having received other immunotargeted therapy targeting the same molecules;\n3. Pregnant or lactating women;\n4. Subjects who have previously suffered from other malignancies, with the following exceptions:\n\n   1. Having received curative therapy, and no known active disease in the ≥ 3 years prior to the enrollment;\n   2. Non melanoma skin cancer subjects who have completed sufficient treatment and no evidence of thecurrent disease;\n5. Subjects with a severe mental disorder;\n6. Subjects with active autoimmune disease requiring immunotherapy;\n7. Having received allogeneic hematopoietic stem cell transplantation;\n8. Subjects with significant cardiovascular diseasesa.uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart disease with cardiac function grade 3 or grade 4 (according to the functional classification method of the New York Heart Association NYHA); b. Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening); c. Clinically significant history of ventricular arrhythmia or unexplained syncope (non vaso-vagal or not due to dehydration);\n9. Subjects with active infectious disease including positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and peripheral blood Hepatitis B virus(HBV) DNA titer is ≥500IU\u002FmL, hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive, human immunodeficiency virus(HIV) antibody positive, syphilis primary screening antibody positive, active pulmonary tuberculosis; or with any significant infection requiring high-grade antibiotics Event;\n10. Subjects with dysfunction of important organssuch as organ function in the following abnormalities:\n\n    1. Serum AST or ALT \\> 2.5×ULN, or \\> 5ULN if liver function is predominantly due to tumor invasion; TBIL \\> 2.5 × ULN, unless the subject is Gilbert's syndrome;\n    2. Serum creatinine\\>2.5mg\u002Fdl;\n    3. Partial prothrombin time or activated partial thromboplastin time or international normalized ratio \\> 1.5×ULN in the absence of anticoagulant therapy;\n11. Participation in other clinical studies or prior treatment with any gene therapy product in the past three months;\n12. Subjects with uncontrolled diabetes mellitus (glycosylated hemoglobin HbAlc \\>8% at screening);13. Highly allergic constitution or history of severe allergies, and having contraindications to cyclophosphamide or fludarabine;\n\n14\\. Feasibility assessment screening demonstrated \\\u003C10% transfection of targeted lymphocytes or underamplification under CD3 \u002F CD28 costimulation (\\\u003C5-fold); 15. Subjects who are considered unsuitable to participate in this trial by the investigator.","75 Years",{"count":347,"type":19},60,[22],"This is a single center, open-label, dose-escalation\u002Fexpansion clinical study to evaluate the safety and effectiveness of Fourth-Generation CAR-T, and determine the recommended dose of the CAR T-cells for patients with Multiple Myeloma，B-cell lymphoma and other hematologic malignancies.",[110,351,26],"B-cell Lymphoma",[353,354,355,356,357,358],"Multiple myeloma","B-cell lymphoma","Hematological malignancy","CAR-T","Safety","Efficacy","2025-01-03",{"date":361,"type":31},"2025-01-06",{"date":363,"type":19},"2025-01-15",{"date":365,"type":19},"2028-12-31",{"name":367,"class":368},"The Third Affiliated Hospital of Southern Medical University","OTHER_GOV",{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":20,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":39},"100560965","phase-2-thymalfasin-and-recombinant-human-il-2-injections-in-treating-lymphocytopenia-for-patients-with-malignant-hematological-tumors-100560965","NCT06584006","Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors","A Phase II, Single-Center, Randomized Controlled Clinical Trial Evaluating the Efficacy of Thymalfasin and Recombinant Human Interleukin-2 Injections in Treating Lymphocytopenia in Patients With Malignant Hematological Tumors","Inclusion Criteria:\n\n1. Patients with histologically confirmed myeloid, B lymphocyte, and plasma cell-derived malignant hematological tumors.\n2. Lymphocyte count ≤ 0.8×109\u002FL or CD4+T cell count ≤ 0.35×109\u002FL.\n3. Age ≥ 18 years, both male and female, with an expected survival period of more than 3 months.\n4. Estimated creatinine clearance rate ≥ 30 mL\u002Fmin.\n5. AST and ALT ≤ 3.0 x ULN. Bilirubin ≤ 1.5 x ULN.\n6. ECOG ≤ 2.\n7. Able to understand and voluntarily provide informed consent.\n\nExclusion Criteria:\n\n1. Active autoimmune disease.\n2. Patients considered to have a malignant T-cell clone.\n3. Within 8 days after chemotherapy for lymphoma and within 14 days after chemotherapy for AML.\n4. Tumor involvement in the bone marrow leading to hematopoietic suppression (neutrophils \\\u003C1.0×10\\^9\u002FL, HB\\\u003C70g\u002FL, PLT\\\u003C50×10\\^9\u002FL).\n5. HIV-positive patients and\u002For active HBV or HCV infection (as evidenced by positive HBV-DNA and HCV-RNA test records).\n6. Patients with chronic respiratory diseases requiring continuous oxygen, or with significant past medical history of kidney, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular diseases.\n7. Immunosuppressive treatment (such as cyclosporine, corticosteroids, ruxolitinib, JAK1\u002F2 inhibitors, etc.) within the past 5 days.\n8. Psychiatric disorders that would interfere with study participation.\n9. Patients who have undergone allogeneic hematopoietic stem cell transplantation.\n10. Consideration of allergy to Thymalfasin or Interleukin-2.\n11. Any other condition that the researcher believes makes the patient unsuitable for this trial.",{"count":206,"type":19},[23],"To evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections in the treatment of lymphocytopenia in patients with malignant hematological tumors",[26,380],"Lymphocytopenia","2024-09-05",{"date":383,"type":31},"2024-09-19",{"date":385,"type":31},"2024-09-01",{"date":387,"type":19},"2028-02-29",{"name":389,"class":38},"The First Affiliated Hospital of Xiamen University",{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":396,"enrollmentInfo":397,"targetDuration":4,"studyType":20,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":407,"leadSponsor":409,"locationsCount":39},"100533441","phase-1-an-open-label-multicenter-phase-i-study-to-evaluate-the-safety-pharmacokinetics-and-preliminary-efficacy-of-yy201-in-patients-with-advanced-solid-tumors-and-hematological-malignancies-100533441","NCT06225856","An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of YY201 in Patients With Advanced Solid Tumors and Hematological Malignancies","Inclusion Criteria:\n\n* 1.Patients fully understand and sign ICF, voluntarily participate in the study, and able to follow and complete all study procedures.\n* 2.Aged 18-80 years (including upper and lower limits), male or female.\n* 3\\. The standard treatment failure (disease progression after treatment or treatment side effects not tolerance), or top treatment, or shall not apply to the current standard treatment for patients with:\n\n  * Surgical excision is confirmed by histology or cytology can't or metastatic patients with advanced solid tumor;\n  * Patients with relapsed or refractory hematologic malignancies\n* 4\\. For patients with advanced solid tumors (dose-escalation phase), at least one tumor lesion that could be evaluated according to RECIST, version 1.1; (Dose-expansion phase) At least one measurable tumor lesion according to RECIST, version 1.1 (a tumor that is located in the previously irradiated area or another locoregional treatment site and is generally not considered a measurable lesion unless there is definite progression or persistence beyond 3 months of radiation).\n* 5\\. In the dose-expansion phase, enrollment was limited to:\n\n  * Advanced solid tumors (predominantly triple-negative breast cancer, pancreatic cancer, and head and neck squamous cell carcinoma) that are sensitive to STAT3 therapy;\n  * Peripheral T-cell lymphoma (PTCL) with STAT3 mutation refractory to or relapsed after at least one or more lines of systemic therapy;\n  * For patients with PTCL, computed tomography performed within 28 days before study entry should show at least one measurable tumor lesion in two vertical directions, with nodal lesions \\> 1.5cm in greatest dimension and extranodal lesions \\> 1.0cm (according to the 2014 lugano criteria).\n  * Relapsed\u002Frefractory acute myeloid leukemia that is sensitive to STAT3 therapy, excluding acute promyelocytic leukemia (APL) and other secondary AML (e.g., MDS transformation, CML in blast phase, etc.)\n* 6\\. ECOG physical condition≤1.\n* 7\\. Patients with advanced primary liver cancer should meet the Child-Pugh liver function grading: grade A and better grade B (≤7).\n* 8\\. Regular check need to meet the following requirements:\n\n  * For advanced solid tumors, adequate bone marrow, liver, and kidney function is required:\n\n    1. Blood system within 14 days (not received blood transfusions or hematopoietic stimulating factor treatment):\n\n       Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Platelet count (PLT) ≥75×10\\^9\u002FL; Hemoglobin (Hb) ≥85g\u002FL;\n    2. Liver function:\n\n       Total bilirubin (TBIL) ≤1.5×ULN; Alanine aminotransferase (ALT) ≤3×ULN; Spread to the liver or liver cancer patient: 5 or less x ULN; Aspartate aminotransferase (AST) or less 3 x ULN; Spread to the liver or liver cancer patient: 5 or less x ULN;\n    3. Renal function:\n\n       Creatinine (Cr) or less 1.5 x ULN; Creatinine clearance (Ccr) (calculated only when creatinine \\> 1.5× ULN) ≥50ml\u002Fmin (calculated according to Cockcroft-Gault formula, see Annex 2 of the protocol);\n    4. Blood coagulation function:\n\n       Activated partial thromboplastin time (APTT) ≤1.5×ULN; International normalized ratio (INR) ≤1.5×ULN;\n    5. Urinary protein:\n\n       Urine routine \u002F24 hours urine protein qualitative ≤1+; Or urine protein qualitative ≥2+, 24 hours urine protein \\\u003C 1g;\n  * For patients with PTCL, routine blood hemoglobin or 80 g\u002FL, neutrophils acuity 1.0 x 10\\^9 \u002F L, 75 x 10\\^9 or higher platelet\u002FL (within 14 days before test without blood transfusion or the use of biological stimulating factor);\n  * For patients with AML, white blood cell counts ≤25 ×10\\^9\u002FL (Hydroxyurea was allowed but not for 3 days before administration of the trial drug);\n* 9\\. Agreed to provide archival tumor-tissue specimens or fresh tissue samples (Dose-expansion phase)\n* 10.Expected survival of at least 3 months.\n* 11\\. Women of childbearing potential had to have a negative serum or urine pregnancy test within 7 days before the first dose. Fertile male or female patients voluntarily during the study period and at the end of the study drug within 30 days of using effective birth control methods, such as abstinence, the double protective screen type cuts, condoms, contraceptive method of oral or injected contraceptives, intrauterine device, etc. All female patients will be considered fertile unless the female patient has undergone natural menopause, artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnophorectomy, or radioactive ovarian irradiation).\n\nExclusion Criteria:\n\n* 1\\. The adverse reactions of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicities without safety risks judged by investigators, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stable with hormone replacement therapy);\n* 2\\. Clinically symptomatic parenchymal or leptomeningeal metastases that were judged by the investigator to be ineligible for enrollment and, for AML patients, known central nervous system (CNS) involvement\n* 3\\. Within 4 weeks before delivery for the first time received chemotherapy, radiation therapy, biological therapy and endocrine therapy, immune therapy, such as antitumor drugs, with the exception of the following situations:\n\n  * Nitrosourea or mitomycin C within 6 weeks before first use of study drug;\n  * Oral fluorouracils and small-molecule targeted agents are administered 2 weeks before first use of the study drug or within the five half-lives of the drug, whichever is longer;\n  * Have antitumor indications for the study of the first use of drugs of traditional Chinese medicines before 2 weeks;\n  * For peripheral blood leukocyte count (WBC \\> 25 x 10\\^9 \u002F L) of the patients, allowing use in treatment of the former and YY201 hydroxyurea control peripheral blood leukocytes;\n  * Prophylactic intrathecal chemotherapy (cytarabine, dexamethasone, and methotrexate) unless it is used to prevent central leukemia.\n* 4\\. Received other unlisted investigational drugs or treatments within 4 weeks before the first dose;\n* 5\\. Previously received STAT3 inhibitor for anti-tumor treatment;\n* 6\\. Major organ surgery (excluding needle biopsy) within 4 weeks before the first dose of medication or requiring elective surgery during the trial;\n* 7\\. Uncontrolled malignant pleural, ascites, or pericardial effusion that was judged by the investigator to be ineligible for enrollment;\n* 8.Unable to oral drug swallowing, or by the researchers determine the condition of the seriously affect the gastrointestinal tract absorption, including but not limited to, such as inflammatory bowel disease (crohn's disease and ulcerative colitis, for example), or malabsorption syndrome, or chronic diarrhea;\n* 9\\. Patients who received a potent inducer or inhibitor of CYP3A4 within 1 week before the first dose or who required continued treatment with these drugs during the study;\n* 10\\. Patients with active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases, or unresected tumor with active bleeding, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigator;\n* 11\\. Thromboembolic events (including stroke events and\u002For transient ischemic attack) occurred within 12 months before the first dose of medication;\n* 12\\. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months before the first dose of medication; Congestive heart failure with New York Heart Association (NYHA) grade ≥2; Left ventricular ejection fraction (LVEF) \\\u003C50%; A history of primary cardiomyopathy, clinically significant prolongation of the QTc interval, or a screening QTc interval \\>470ms in women and \\>450ms in men;\n* 13\\. Patients with active or previous autoimmune diseases with potential recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), excluding patients with clinically stable autoimmune thyroid diseases and type I diabetes mellitus;\n* 14\\. Prior immunotherapy with grade ≥3 irAE or grade ≥2 immune-related myocarditis;\n* 15\\. Researchers to determine the clinical significance of 3 or more electrolyte abnormalities\n* 16\\. Patients with active infection requiring antiinfective treatment or unexplained fever (body temperature \\>38.5 ° C) during screening or before the first dose of medication;\n* 17\\. Patients with active pulmonary tuberculosis (TB) who are receiving anti-TB treatment or have received anti-TB treatment within 1 year before the first dose; Known human immunodeficiency virus (HIV) infection; Patients with a history of hepatitis B were in the stage of active infection (HBsAg positive and HBV-DNA \\> the detection limit of the research center); Patients with a history of hepatitis C were in the active infection stage, defined as positive HCV antibody test and HCV RNA above the local detection cut-off value;\n* 18\\. Patients who have received hematopoietic stem cell transplantation (HSCT) within 60 days prior to the start of study treatment, or are receiving immunosuppressive therapy after HSCT at screening, or have graft-versus-host disease (GVHD) requiring drug control:\n\n  •Patients treated with fixed oral dose and\u002For topical corticosteroids for cutaneous GVHD may be enrolled with approval of the Sponsor.\n* 19\\. Women who are pregnant (positive pregnancy test within 14 days before medication) or are breastfeeding.\n* 20\\. Men with fertility needs;\n* 21\\. Patients with known alcohol or drug dependence;\n* 22\\. Patients judged by the investigator that may not be able to comply with all study procedures;\n* 23\\. Any other disease, metabolic abnormality, abnormal physical examinations or laboratory abnormality with significant clinical significance. Investigator reasonably suspects that the patient has a disease or state that is not suitable for using of the study drug, or will affect interpretation of study results, or put the patient at high risk.","80 Years",{"count":398,"type":19},96,[22],"This is a multicenter, open-label, phase I clinical study of YY201 in the patients with relapsed\u002Frefractory lymphomas and relapsed\u002Frefractory large granular lymphocytic leukemia who failed or cannot tolerate standard treatment.",[402,26],"Advanced Solid Tumor","2024-01-29",{"date":405,"type":31},"2024-01-31",{"date":193,"type":31},{"date":408,"type":19},"2026-12-30",{"name":410,"class":292},"Shanghai Yuyao Biotech Co., Ltd."]