[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-burkitt-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-burkitt-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100648835","phase-2-testing-the-addition-of-a-new-anti-cancer-drug-glofitamab-to-usual-chemotherapy-for-burkitt-and-double-hit-lymphoma-100648835",false,"NCT07724457","Testing the Addition of a New Anti-Cancer Drug, Glofitamab to Usual Chemotherapy for Burkitt and Double Hit Lymphoma","A Randomized Phase 2\u002F3 Study the Bispecific Antibody (BsAb), Glofitamab, Plus Chemoimmunotherapy in Newly Diagnosed and Relapsed Burkitt and High-Grade (Double Hit) B-Cell Lymphomas With MYC and BCL2 Rearrangements","Inclusion Criteria:\n\n* BURKITT LYMPHOMA (BL) COHORT 1: Histologically confirmed Burkitt lymphoma by International Consensus Classification criteria. Patients with Burkitt lymphoma must have one or more of the following adverse risk factors at diagnosis:\n\n  * Stage III or IV disease\n  * Elevated lactate dehydrogenase (LDH) greater than institutional upper limit of normal (ULN)\n  * Tumor mass ≥ 7 cm\n* BL COHORT 1: No prior treatment except for pre-phase chemotherapy, pre-phase corticosteroids, or one cycle of chemotherapy as described below.\n\n  * Pre-phase chemotherapy with corticosteroids or cyclophosphamide\u002Fprednisone is permitted prior to enrollment.\n  * One cycle of prior chemotherapy (for example, cyclophosphamide, doxorubicin, vincristine and prednisone \\[CHOP\\], Polatuzumab-cyclophosphamide doxorubicin and prednisone \\[CHP\\], cyclophosphamide, vincristine, doxorubicin and methotrexate \\[CODOXM\\], or etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin \\[EPOCH\\] \\[with or without rituximab\\]) may be administered no more than 21 days prior to enrollment.\n  * Patients enrolling on study after one cycle of prior anthracycline containing therapy will start the study therapy in cycle 2 and cycle 2 must occur no later than 22-36 days after the start of cycle 1. (If feasible, cycle 2 should start on day 22, but +14 days is permitted to permit recovery from toxicity in cycle 1)\n* BL COHORT 1: Age ≥ 18 years\n* BL COHORT 1: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. ECOG performance status of 3 is permitted if related to lymphoma\n* BL COHORT 1: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3 (unless attributable to lymphoma)\n* BL COHORT 1: Platelet count ≥ 75,000\u002Fmm\\^3 (unless attributable to lymphoma)\n* BL COHORT 1: Calculated (Calc.) creatinine clearance ≥ 50 mL\u002Fmin (unless attributable to lymphoma)\n* BL COHORT 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN (unless attributable to lymphoma)\n* BL COHORT 1: Total bilirubin ≤ 2.0 mg\u002FdL (unless due to Gilbert's syndrome) (unless attributable to lymphoma)\n* BL COHORT 1: International normalization ratio (INR) OR prothrombin time (PT) \\> 1.5 x institutional ULN (unless attributable to lymphoma)\n* BL COHORT 1: Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) \\> 1.5 x institutional ULN (unless attributable to lymphoma)\n* BL COHORT 1: Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 28 days prior to registration is required\n* BL COHORT 1: Patients with prior malignancy or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (i.e. anthracycline dosing that will exceed recommended lifetime maximum dosing) are eligible for this trial\n* BL COHORT 1: Patients with HIV are eligible but must be on effective anti-retroviral therapy, with undetectable viral load within 6 months of enrollment\n* BL COHORT 1: Patients with a history of hepatitis B who are hepatitis B (HepB) surface antigen (Ag) positive and\u002For HepB core antibody (Ab) positive with undetectable Hep B viral load who start suppressive antiviral therapy prior to chemotherapy are eligible\n* BL COHORT 1: Patients with a history of hepatitis C infection that have been treated for hepatitis C virus (HCV) and have an undetectable HCV viral load are eligible\n* BL COHORT 1: No active ischemic heart disease or congestive heart failure, AND adequate cardiac function defined as ejection fraction of ≥ 45%\n* BL COHORT 1: Patients with CSF\u002Fleptomeningeal involvement at diagnosis are eligible. Patients with parenchymal brain involvement at diagnosis are NOT eligible\n* BL COHORT 1: Patients requiring \\> 10 mg\u002Fday of prednisone or equivalent, for the treatment of conditions other than the control of lymphoma related symptoms, are NOT eligible\n* BL COHORT 1: Patients with major surgery within 4 weeks other than for diagnosis of lymphoma are NOT eligible\n* BL COHORT 1: Patients with known active infections, or reactivation of a latent infection (excluding fungal infections of nail bed, hepatitis B on suppressive therapy or treated hepatitis C) requiring hospitalization or treatment with IV antibiotics within 4 weeks of study treatment are NOT eligible\n* BL COHORT 1: Patients with a prior history of hemophagocytic lymphohistocytosis (HLH) are NOT eligible\n* BL COHORT 1: Patients with a history of autoimmune disease (including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis) are NOT eligible.\n\nHowever, patients with autoimmune related hypothyroidism on a stable dose of thyroid replacement hormone, patients with a history of lymphoma related immune thrombocytopenic purpura or hemolytic anemia, and patients with type 1 or type 2 diabetes on a stable insulin regimen are eligible to enroll. In addition, patients with eczema, lichen simplex chronicus, or vitiligo with dermatologic manifestations only may also enroll if the rash covers \\\u003C 10% of body surface area and the disease is well controlled and requires only topical corticosteroids.\n\nLastly, patients treated with prior immunotherapeutic agents with a history of any grade 3 events (except for grade 3 endocrinopathy managed with replacement therapy) or grade 1-2 events that did not resolve to baseline with treatment discontinuation are NOT eligible.\n\n* BL COHORT 1: Patients with a history of progressive multifocal leukoencephalopathy (PML) are NOT eligible\n* BL COHORT 1: Patients who have received live, attenuated vaccines within 4 weeks prior to cycle 1 day (D) 1 of study treatment are NOT eligible\n* DOUBLE HIT LYMPHOMA (DHL) COHORT 2: Histologically confirmed high grade\u002Fdouble hit B-cell lymphoma with MYC and BCL2 translocations by International Consensus Classification (ICC) or World Health Organization (WHO) criteria. Fluorescence in situ hybridization (FISH) For MYC and BCL2 translocations must be performed by the referring site and must be positive for translocations of BOTH MYC and BCL2. Patients found to have BCL6 translocations in addition to BOTH MYC and BCL2 (so called \"triple hit lymphoma\") are eligible\n* DHL COHORT 2: Stage II-IV disease per Lugano staging classification\n* DHL COHORT 2: No prior treatment except for pre-phase chemotherapy, pre-phase corticosteroids, or one cycle of chemotherapy as described below.\n\n  * Pre-phase chemotherapy with corticosteroids or cyclophosphamide\u002Fprednisone is permitted prior to enrollment.\n  * One cycle of prior chemotherapy (for example, CHOP, Polatuzumab-CHP, or EPOCH (with or without Rituximab)) may be administered no more than 21 days prior to enrollment.\n  * Patients enrolling on study after one cycle of prior anthracycline containing therapy will start the study therapy in cycle 2 and cycle 2 must occur no later than 22-36 days after the start of cycle 1. (If feasible, cycle 2 should start on day 22, but +14 days is permitted to permit recovery from toxicity in cycle 1)\n* DHL COHORT 2: Age ≥ 18 years\n* DHL COHORT 2: ECOG performance status ≤ 2. ECOG performance status of 3 is permitted if related to lymphoma\n* DHL COHORT 2: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^ 3 (unless attributable to lymphoma)\n* DHL COHORT 2: Platelet Count ≥ 75,000\u002Fmm\\^3 (unless attributable to lymphoma)\n* DHL COHORT 2: Calc. Creatinine Clearance ≥ 50 mL\u002Fmin (unless attributable to lymphoma)\n* DHL COHORT 2: AST(SGOT)\u002FALT(SGPT) ≤ 3 x institutional ULN (unless attributable to lymphoma)\n* DHL COHORT 2: Total Bilirubin ≤ 2.0 mg\u002FdL (unless due to Gilbert's Syndrome) (unless attributable to lymphoma)\n* DHL COHORT 2: INR OR PT \\> 1.5 x institutional ULN (unless attributable to lymphoma)\n* DHL COHORT 2: PTT or aPTT \\> 1.5 x institutional ULN (unless attributable to lymphoma)\n* DHL COHORT 2: Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 28 days prior to registration is required\n* DHL COHORT 2: Patients with prior malignancy or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (i.e. anthracycline dosing that will exceed recommended lifetime maximum dosing) are eligible for this trial\n* DHL COHORT 2: Patients with HIV are eligible but must be on effective anti-retroviral therapy, with undetectable viral load within 6 months of enrollment\n* DHL COHORT 2: Patients with a history of hepatitis B who are HepB surface Ag positive and\u002For HepB core Ab positive with undetectable Hep B viral load who who start suppressive antiviral therapy prior to chemotherapy are eligible\n* DHL COHORT 2: Patients with a history of hepatitis C infection that have been treated for HCV and have an undetectable HCV viral load are eligible\n* DHL COHORT 2: No active ischemic heart disease or congestive heart failure, AND adequate cardiac function defined as ejection fraction of ≥ 45%\n* DHL COHORT 2: Patients with CSF\u002Fleptomeningeal involvement at diagnosis are eligible. Patients with parenchymal brain involvement at diagnosis are NOT eligible\n* DHL COHORT 2: Corticosteroid use: Patients requiring \\> 10 mg\u002Fday of prednisone or equivalent, for the treatment of conditions other than the control of lymphoma related symptoms, are NOT eligible\n* DHL COHORT 2: Patients with major surgery within 4 weeks other than for diagnosis of lymphoma are NOT eligible\n* DHL COHORT 2: Patients with known active infections, or reactivation of a latent infection (excluding fungal infections of nail bed, hepatitis B on suppressive therapy, or treated hepatitis C) requiring hospitalization or treatment with IV antibiotics within 4 weeks of study treatment are NOT eligible\n* DHL COHORT 2: Patients with a prior history of HLH are NOT eligible\n* DHL COHORT 2: Patients with a history of autoimmune disease (including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis) are NOT eligible.\n\nHowever, patients with autoimmune related hypothyroidism on a stable dose of thyroid replacement hormone, patients with a history of lymphoma related immune thrombocytopenic purpura or hemolytic anemia, and patients with type 1 or type 2 diabetes on a stable insulin regimen are eligible to enroll. In addition, patients with eczema, lichen simplex chronicus, or vitiligo with dermatologic manifestations only may also enroll if the rash covers \\\u003C 10% of body surface area and the disease is well controlled and requires only topical corticosteroids.\n\nLastly, patients treated with prior immunotherapeutic agents with a history of any grade 3 events (except for grade 3 endocrinopathy managed with replacement therapy) or grade 1-2 events that did not resolve to baseline with treatment discontinuation are NOT eligible\n\n* DHL COHORT 2: Patients with a history of PML are NOT eligible\n* DHL COHORT 2: Patients who have received live, attenuated vaccines within 4 weeks prior to cycle 1 D1 of study treatment are NOT eligible\n* RELAPSED BL AND HGL COHORT 3: Histologically confirmed Burkitt lymphoma by International Consensus Classification criteria\n* RELAPSED BL AND HGL COHORT 3: Patients must have relapsed or refractory disease after at least one prior treatment with chemotherapy or chemoimmunotherapy.\n\n  * Prior radiotherapy in addition or in conjunction with prior chemotherapy is permitted.\n  * Patients who have previously received a bispecific antibody (BsAb) are NOT eligible. However, patients enrolled to the standard arms on cohorts 1 and 2 of this trial who did not receive glofitimab and have relapsed or refractory disease are eligible to enroll on cohort 3.\n  * Prior treatment with systemic immunotherapeutic agents including antibody drug conjugates, radio-immunoconjugates, or immune\u002Fcytokine direct therapy must have occurred within 3 weeks or five half-lives of the drug, whichever is shorter\n* RELAPSED BL AND HGL COHORT 3: Age ≥ 18 years\n* RELAPSED BL AND HGL COHORT 3: ECOG Performance Status ≤ 2. ECOG performance status of 3 is permitted if related to lymphoma\n* RELAPSED BL AND HGL COHORT 3: Absolute Neutrophil Count (ANC) ≥ 1,000\u002Fmm\\^3 (unless attributable to lymphoma)\n* RELAPSED BL AND HGL COHORT 3: Platelet Count ≥ 75,000\u002Fmm\\^3 (unless attributable to lymphoma)\n* RELAPSED BL AND HGL COHORT 3: Calc. Creatinine Clearance ≥ 50 mL\u002Fmin (unless attributable to lymphoma)\n* RELAPSED BL AND HGL COHORT 3: AST(SGOT)\u002FALT(SGPT) ≤ 3 x institutional ULN (unless attributable to lymphoma)\n* RELAPSED BL AND HGL COHORT 3: Total bilirubin ≤ 2.0 mg\u002FdL (unless due to Gilbert's Syndrome) (unless attributable to lymphoma)\n* RELAPSED BL AND HGL COHORT 3: INR OR PT \\> 1.5 x institutional ULN (unless due to Gilbert's Syndrome) (unless attributable to lymphoma)\n* RELAPSED BL AND HGL COHORT 3: PTT or aPTT \\> 1.5 x institutional ULN (unless due to Gilbert's Syndrome) (unless attributable to lymphoma)\n* RELAPSED BL AND HGL COHORT 3: Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 28 days prior to registration is required\n* RELAPSED BL AND HGL COHORT 3: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (i.e. anthracycline dosing that will exceed recommended lifetime maximum dosing) are eligible for this trial\n* RELAPSED BL AND HGL COHORT 3: Patients with HIV are eligible but must be on effective anti-retroviral therapy, with undetectable viral load within 6 months of enrollment\n* RELAPSED BL AND HGL COHORT 3: Patients with a history of hepatitis B who are HepB surface Ag positive and\u002For HepB core Ab positive with undetectable Hep B viral load who are taking suppressive antiviral therapy are eligible\n* RELAPSED BL AND HGL COHORT 3: Patients with a history of hepatitis C infection that have been treated for HCV and have an undetectable HCV viral load are eligible\n* RELAPSED BL AND HGL COHORT 3: No active ischemic heart disease or congestive heart failure, AND adequate cardiac function defined as ejection fraction of ≥ 45%\n* RELAPSED BL AND HGL COHORT 3: Patients with CSF\u002Fleptomeningeal involvement at diagnosis are eligible. Patients with parenchymal brain involvement at diagnosis are NOT eligible\n* RELAPSED BL AND HGL COHORT 3: Corticosteroid use: Patients requiring \\> 10 mg\u002Fday of prednisone or equivalent, for the treatment of conditions other than the control of lymphoma related symptoms, are NOT eligible\n* RELAPSED BL AND HGL COHORT 3: Patients with major surgery within 4 weeks other than for diagnosis of lymphoma are NOT eligible\n* RELAPSED BL AND HGL COHORT 3: Patients with known active infections, or reactivation of a latent infection (excluding fungal infections of nail bed, hepatitis B on suppressive therapy, or treated hepatitis C) requiring hospitalization or treatment with IV antibiotics within 4 weeks of study treatment are NOT eligible\n* RELAPSED BL AND HGL COHORT 3: Patients with a prior history of HLH are NOT eligible\n* RELAPSED BL AND HGL COHORT 3: Patients with a history of autoimmune disease (including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis) are NOT eligible.\n\nHowever, patients with autoimmune related hypothyroidism on a stable dose of thyroid replacement hormone, patients with a history of lymphoma related immune thrombocytopenic purpura or hemolytic anemia, and patients with type 1 diabetes on a stable insulin regimen are eligible to enroll. In addition, patients with eczema, lichen simplex chronicus, or vitiligo with dermatologic manifestations only may also enroll if the rash covers \\\u003C 10% of body surface area and the disease is well controlled and requires only topical corticosteroids.\n\nLastly, patients treated with prior immunotherapeutic agents with a history of any grade 3 events (except for grade 3 endocrinopathy managed with replacement therapy) or grade 1-2 events that did not resolve to baseline with treatment discontinuation are NOT eligible\n\n* RELAPSED BL AND HGL COHORT 3: Patients with a history of PML are NOT eligible\n* RELAPSED BL AND HGL COHORT 3: Patients who have received live, attenuated vaccines within 4 weeks prior to cycle 1 D1 of study treatment are NOT eligible","ALL","18 Years",{"count":19,"type":20},271,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This phase II\u002FIII trial tests adding glofitamab to standard of care chemoimmunotherapy in patients with Burkitt and high grade (double hit) B- cell lymphomas that are newly diagnosed, that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Glofitamab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Obinutuzumab and rituximab are also monoclonal antibodies. They bind to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make DNA and may kill cancer cells. Chemotherapy drugs, such as cytarabine and ifosfamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Giving glofitamab with standard of care chemotherapy may work well for the treatment of newly diagnosed, relapsed or refractory Burkitt and high grade (double hit) B- cell lymphomas.",[27,28,29,30],"Recurrent Burkitt Lymphoma","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements","Refractory Burkitt Lymphoma","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements","NOT_YET_RECRUITING","2026-08-18",{"date":34,"type":35},"2026-08-19","ACTUAL",{"date":37,"type":20},"2026-10-30",{"date":39,"type":20},"2033-11-01",{"name":41,"class":42},"National Cancer Institute (NCI)","NIH",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100296220","combination-chemotherapy-in-treating-patients-with-relapsed-or-refractory-acute-lymphoblastic-leukemia-lymphoblastic-lymphoma-burkitt-lymphomaleukemia-or-double-hit-lymphomaleukemia-100296220","NCT03136146","Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma\u002FLeukemia, or Double-Hit Lymphoma\u002FLeukemia","Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed\u002FRefractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)","Inclusion Criteria:\n\n* Relapsed\u002Frefractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL):\n\n  * Relapsed and\u002For refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II)\n  * Relapsed and\u002For refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia\u002Flymphoma or \"double-hit\" leukemia\u002Flymphoma (phase II only)\n* At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset\n* Age older than 15 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 3 (There may be certain patients with performance status \\[PS\\] 3 in the context of rapidly proliferative\u002Frefractory ALL who would benefit from this regimen. We don't want to exclude such patients who may derive benefit from this salvage regimen)\n* Serum bilirubin =\\\u003C 1.5 mg\u002FdL\n* Serum glutamate pyruvate transaminase (SGPT) =\\\u003C 3 x upper limit normal (ULN), with exception for Gilbert's syndrome\n* Estimated creatinine clearance or GFR (glomerular filtration rate) \\>= 50 mL\u002Fmin\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active \\>= grade 3 peripheral neuropathy\n* Active hepatic graft-versus-host disease\n* Known positivity for hepatitis B or C\n* Pregnancy\n* Breast feeding","15 Years",{"count":52,"type":20},42,[23],"This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma\u002Fleukemia, or double-hit lymphoma\u002Fleukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone and bortezomib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.",[56,57,58,27,59,60,61,62,29,63,64],"Recurrent Acute Lymphoblastic Leukemia","Recurrent Adult Lymphoblastic Lymphoma","Recurrent Burkitt Leukemia","Recurrent Childhood Lymphoblastic Lymphoma","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory Acute Lymphoblastic Leukemia","Refractory Burkitt Leukemia","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory Lymphoblastic Lymphoma","RECRUITING","2026-08-07",{"date":68,"type":35},"2026-08-10",{"date":70,"type":35},"2017-08-09",{"date":72,"type":20},"2027-08-01",{"name":74,"class":75},"M.D. Anderson Cancer Center","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":76},"100161234","phase-1-inotuzumab-ozogamicin-and-combination-chemotherapy-in-treating-patients-with-acute-lymphoblastic-leukemia-100161234","NCT01371630","Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia","Phase I\u002FII Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)","Inclusion Criteria:\n\n1. Patients age 60 years or older with previously untreated ALL pre-B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL Minimal prior therapy (less than 1 week of steroids, vincristine, and\u002For 1 dose of anthracycline or alkylating agents) are allowed.\n2. Patients unfit ≥ 18 - \\\u003C 60 years of age with previously untreated ALL pre- B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL (includes patients initiated on first cycle of hyper-CVAD before cytogenetics known. These patients could have received one or two cycles of chemotherapy with or without other TKIs and still eligible.\n\n   These patients are defined as having at least one of the below comorbidities:\n   1. ECOG performance status ≥ 2\n   2. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)\n   3. Severe pulmonary disorder (e.g., DLCO ≤ 65% or FEV1 ≤ 65%)\n   4. Creatinine clearance \\\u003C 45 mL\u002Fmin, and\n   5. Hepatic disorder with total bilirubin \\> 1.5 x upper limit of normal\n\n   \u003C!-- -->\n\n   1. If they achieved CR, they are assessable only for event-free and overall survival, or\n   2. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival\n3. Patients age 60 years and older unfit for intensive chemotherapy with one or more comorbidities (e.g., renal insufficiency, heart disease, cardio-vascular disease, uncontrolled hypertension, diabetes, respiratory problems, among others) and a PS of ≥ 1. All ages of Jehovah's witness are eligible.\n4. Zubrod performance status 0-3.\n5. Adequate liver function (bilirubin \\\u003C 1.95 mg\u002FdL and SGPT or SGOT \\\u003C 3 x upper limit of normal \\[ULN\\], unless considered due to tumor), and renal function (estimated creatinine clearance ≥50 mL\u002Fmin\u002F1.73 m2). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \\\u003C 2.6 mg\u002FdL and creatinine \\\u003C 3 mg\u002FdL.\n6. Provision of written informed consent.\n7. Patients in first remission are eligible.\n8. Patients with refractory-relapsed ALL, Burkitt lymphoma, Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, and high-grade B-cell lymphoma not otherwise specified with marrow involvementBof any age are eligible.\n\nExclusion Criteria:\n\n1. Newly diagnosed Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma.\n2. Patient with active heart disease (NYHA class \\> 3 as assessed by history and physical examination).\n3. Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \\\u003C 40% are excluded.\n4. Patients with active hepatitis are excluded.\n5. Pregnant or breast-feeding women are excluded.",{"count":85,"type":20},276,[87,23],"PHASE1","This phase I\u002FII trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating patients with acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.",[90,91,92,93,94,95,27,96,29],"B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","Burkitt-Like Lymphoma With 11q Aberration","High Grade B-Cell Lymphoma With MYC and BCL2 and\u002For BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Recurrent B Acute Lymphoblastic Leukemia","Refractory B Acute Lymphoblastic Leukemia","2026-07-14",{"date":99,"type":35},"2026-07-15",{"date":101,"type":35},"2011-08-26",{"date":103,"type":20},"2027-12-25",{"name":74,"class":75}]