[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypogammaglobulinemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypogammaglobulinemia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,77,111,138,165],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100652704","phase-1-base-edited-hematopoietic-stemprogenitor-cell-gene-therapy-for-treatment-of-cxcr4-whim-100652704",false,"NCT07775313","Base-Edited Hematopoietic Stem\u002FProgenitor Cell Gene Therapy for Treatment of CXCR4-WHIM","Phase 1\u002F2 Base-Edited Hematopoietic Stem\u002FProgenitor Cell Gene Therapy for Treatment of CXCR4-WHIM","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged \\>= 3 years and weighing \\>=15 kg.\n* Confirmed CXCR c.1000C\\>T, pR334X mutation.\n* Ability to undergo apheresis for stem cell collection.\n* Medical lab data (historical) of neutropenia, or B cell dysfunction (low or absent IgG levels, or on IV gamma globulin.\n* Expected survival of at least 120 days.\n* Must be willing to have blood and tissue samples stored.\n* Participants of reproductive potential must agree to consistently use effective contraception from start of busulfan conditioning through at least one-year post-treatment. Acceptable forms of contraception are:\n\n  * Hormonal contraception in continuously effective use.\n  * Male or female condom with spermicide as indicated.\n  * Diaphragm or cervical cap in consistent and effective pattern of use with a spermicide.\n  * Intrauterine device in-situ\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Acute onset infection as indicated by symptoms such as persistent fevers, or imaging (new pneumonia on CT for example), isolated pathogen and requiring medical intervention.\n* Severe liver dysfunction with transaminases \\> 6 fold upper limit will be excluded until approval by hepatology consult who will provide mitigating plans for liver protection.\n* Renal dysfunction-serum creatinine \\>3.0 x ULN.\n* Coagulation dysfunction- Prothrombin INR or Partial thromboplastin time \\>2 x ULN (patients on controlled anticoagulation agents will not be excluded for therapeutic levels).\n* Known hypersensitivity to busulfan or any component of the product.\n* Contraindications for administration of busulfan, including but not limited to: hypersensitivity, chronic lymphocytic leukemia, acute leukemia in blastic crisis, pregnancy, or lactation.\n* Childhood malignancy (occurring before 18 years of age) in the participant or a first degree relative, or previously diagnosed known genotype of the participant conferring a predisposition to cancer unless approved by the with appropriate consultants and approved by the study PI (no DNA or other testing for cancer predisposition genes will be performed as part of the screen for this protocol).\n* Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant, or would preclude the participant from successful study completion.","ALL","3 Years","75 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nWarts, hypogammaglobulinemia, infections and myelokathexis syndrome (WHIMs) is a rare disorder that affects the immune system. People with WHIMs can have severe infections all over their body. WHIMs is caused by a mutation in the CXCR4 gene. Treatment with drugs can help control the infections but does not cure the disorder. Researchers want to try a treatment where they collect stem cells from a person with WHIMS, use base-editing to replace the bad gene with a healthy version, and return the new cells to the person. This could cure WHIMs.\n\nObjective:\n\nTo test a treatment using base-edited stem cells in people with WHIMs.\n\nEligibility:\n\nPeople aged 3 years and older with WHIMs.\n\nDesign:\n\nThe study has 4 stages.\n\nStage 1: Screening. Participants will be screened at 1 or more visits. They will have a physical exam with blood tests. A sample of tissue and fluid (biopsy) will be taken from the bone marrow in the hip.\n\nStage 2: Apheresis. Blood will be taken from the body through a needle; the blood will pass through a machine that separates out the stem cells. The remaining blood will be returned to the body through a different needle. The collected stem cells will undergo gene editing.\n\nStage 3: Treatment. Participants will stay in the hospital for about 4 weeks. They will receive 3 drugs to prepare their body for the procedure. Then the edited stem cells will be returned to their bloodstream. They will stay in the hospital until they recover.\n\nStage 4: Follow-up. Participants will have 8 follow-up visits over 5 years. Long-term visits will continue for 15 years.",[28,29,30,31,32],"WHIM","Warts","Hypogammaglobulinemia","Immunodeficiency","Myelokathexis",[34,35],"Gene Editing","base editing","NOT_YET_RECRUITING","2026-08-20",{"date":39,"type":40},"2026-08-21","ACTUAL",{"date":42,"type":21},"2026-08-26",{"date":44,"type":21},"2033-12-31",{"name":46,"class":47},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100609925","phase-3-supporting-weak-immune-system-during-autoimmune-therapy-testing-panzyga-to-prevent-infections-100609925","NCT07220915","Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients With Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment With B-cell Depletion Therapy (\"PROTECT\")","Inclusion Criteria:\n\nPatients who meet all of the following criteria will be eligible to participate in the study:\n\n1. Are ≥18 years of age at time of informed consent, have been diagnosed with a rheumatic or autoimmune condition, received their last BCDT dose within 3 months of Screening, and have the intention to receive BCDT during study participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis\u002Fmyositis, SLE, SS, IIM, MCTD, UCTD, myasthenia gravis, autoimmune encephalitis, CIDP, and neuromyelitis optica spectrum disorder). Other rheumatic and autoimmune conditions may also be acceptable with approval from the Medical Monitor.\n2. Have hypogammaglobulinemia (IgG levels \\\u003C5 g\u002FL as confirmed by the central laboratory).\n3. Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements..\n4. Are willing and able to comply with a highly effective contraception method during and for 30 days after the treatment period. Contraceptive use by men and women of childbearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from participation in the study:\n\n1. Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component\n2. Have a current major infection at Screening or had \\>1 major infection within 6 months prior to Baseline\n3. Have a history of thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease (Fontaine IV) within 6 months prior to Baseline\n4. Have a known IgA deficiency with antibodies to IgA\n5. Have a known blood hyperviscosity or other hypercoagulable states\n6. Have been diagnosed with primary immunodeficiency.\n7. Have a severe liver disease, with signs of ascites or hepatic encephalopathy\n8. Have a severe kidney disease (as defined by eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n9. Have a body weight \\>140 kg\n10. HIV infection at Screening (defined for the study as positive HIV NAT test or reactive HIV- 1\u002F2 antigen\u002Fantibody immunoassay followed by positive HIV-1\u002FHIV-2 antibody differentiation immunoassay)\n11. Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and\u002For low HBV titers, who will not receive targeted antiviral therapy while participating in the study, and patients with active HBV, defined as high HBV titers.\n12. Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR).\n13. Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study\n14. Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration\n15. Are participating or plan to participate in another study that is either blinded or involves an investigational medicinal product within 3 months prior to Baseline or during the course of this study. Participation in observational or open-label studies involving an approved product may be permitted after consultation with the Medical Monitor.\n16. If female, are pregnant or lactating\n17. Are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development, in the opinion of the Investigator","18 Years",{"count":58,"type":21},360,[60],"PHASE3","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy",[30,63,64,65],"Autoimmune Conditions","Rheumatic Conditions","Infections","RECRUITING","2026-08-10",{"date":69,"type":40},"2026-08-12",{"date":71,"type":40},"2026-06-10",{"date":73,"type":21},"2029-12",{"name":75,"class":76},"Octapharma","INDUSTRY",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100488822","phase-3-a-study-to-evaluate-efficacy-safety-and-pk-of-xembifystandard-medical-treatment-smt-compared-to-placebosmt-to-prevent-infections-in-participants-with-hgg-and-recurrent-or-severe-infections-associated-with-b-cell-chronic-lymphocytic-leukemia-multiple-myeloma-and-non-hodgkin-lymphoma-100488822","NCT05645107","A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","EXCELL","Inclusion Criteria:\n\n* Participants ≥18 years of age at screening visit\n* Participants with documented and confirmed diagnosis of any of the below diseases:\n\n  * B-cell CLL according to International Workshop on CLL (iwCLL) criteria and RAI staging of intermediate (1 and 2) or high (3 and 4)\n  * MM according to the International Myeloma Working Group criteria (IMWG), R-ISS stage II or, III; or\n  * Histologically confirmed diagnosis of B-Cell NHL, Stage III or above (IV, Progressive\u002Frefractory, or recurrent\u002Frelapsed stage) according to the Lugano Classification.\n* Participants with HGG with IgG levels less than 5 g\u002FL. (Note: For MM subjects, the IgG level is adjusted by subtracting the M-protein \\[Mspike\\] to reflect the true polyclonal IgG concentration.)\n* Participants with documented history of at least one severe bacterial infection (bacterial or viral) or recurrent bacterial\u002Fviral infections (that is., ≥ 3 infections) within 12 months before the screening visit. Severe bacterial\u002Fviral infections ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grades).\n\nExclusion Criteria:\n\n* Participants with documented history of hematopoietic stem cell transplant (allogenic transplant in the previous 24 months, and autologous transplant in the previous 3 months) before Screening visit.\n* Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement treatment (i.e., prior immune globulin replacement therapy) within 6 months before the screening visit.\n* Participants with active infections at time of screening visit. Specific supportive anti-infective prophylactic defined in the CLL National Comprehensive Cancer Network (NCCN) or iwCLL guidelines and\u002For local\u002Finternational guidelines for the CLL, and defined in local\u002Finternational guidelines for MM and NHL are allowed, or recommended in the updated labelling of specific active target disease medicines used during the participation in the trial is also allowed.\n* Participants with active second malignancies.\n* Participants with known primary immunodeficiency (PI).\n* Participants with a life expectancy less than 1.5 years.\n* Participants with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the subject at undue medical risk.\n* Participants have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product.\n* Participants have a history of blistering skin disease, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study based upon the Investigator's discretion.\n* Participants have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement).\n* Participants with severe known kidney disease \\[as defined by estimated glomerular filtration rate \\[eGFR\\] less than (\\<) 30 milliliter (mL)\u002Fmin\u002F1.73 square meter (m2)\\] as determined by the Principal Investigator.\n* Participants that have liver enzyme levels (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], gammaglutamyl transferase \\[GGT\\], or lactate dehydrogenase \\[LDH\\]) greater than 3 times the upper limit of normal (ULN) at the Screening Visit as defined by the testing laboratory.\n* Participants have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (example, myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis.\n* Participants currently have a known hyperviscosity syndrome or hypercoagulable states.\n* Participants have a known previous infection or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.\n* Participants with non-controlled arterial hypertension (systolic blood pressure \\[SBP\\] greater than 140 millimeters of mercury (mmHg) and\u002For diastolic blood pressure \\[DBP\\] greater than 90 mmHg), and\u002For a heart rate (HR) greater than100 bpm.\n* Participants with known substance or prescription drug abuse within 12 months before the Screening Visit.\n* Participants have participated in another clinical trial within 30 days prior to screening (observational studies without investigative treatments \\[non-interventional\\] are permitted).",{"count":86,"type":21},386,[60],"The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.",[30,90,91,92,93],"Bacterial Infections","B-cell Chronic Lymphocytic Leukemia","Multiple Myleoma","Non-Hodgkin Lymphoma",[95,96,97,98,99,100],"XEMBIFY","CLL","SMT","Hypogammaglobulinemia (HGG)","MM","NHL","2026-07-28",{"date":103,"type":40},"2026-07-29",{"date":105,"type":40},"2022-12-26",{"date":107,"type":21},"2029-08",{"name":109,"class":76},"Grifols Therapeutics LLC",62,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":48},"100466749","immunoglobulin-deficiency-a-treatable-cause-of-fatigue-in-patients-with-multiple-sclerosis-ms-100466749","NCT05357781","Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?","Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)? - A Prospective Observational Fatigue Trial","FatIgG","Inclusion Criteria:\n\n* Diagnosis of Multiple Sclerosis following McDonald 2017-Criteria\n* Age 18-65 years\n* Stable MS disease at inclusion (definition: no clinical relapse, no MRI activity, stable disability within the last 12 months)\n* Unchanged immunotherapy within the last 12 months\n* Expanded Disability Status Scale (EDSS) level \\\u003C4 points indicating fully ambulatory patients.\n* Capability of written informed consent\n\nExclusion Criteria:\n\n* Severe depression (definition: Beck Depression Index-II (BDI-II) ≥29 points) or other established psychiatric diagnosis\n* Immunodeficiency other than hypogammaglobulinemia\n* Immunglobulin replacement therapy or indication for immunoglobulin replacement therapy\n* Severe Sleepiness (definition: Epworth-Sleepiness-Scale (ESS) \\>16 points)\n* Fatigue aggravating factors such: liver\u002Frenal\u002Fthyroid dysfunction, substance abuse, medication (tranquilizers \u002Fantiepileptics\u002Fpsychopharmaceuticals), chronic infectious disease (like hepatitis\u002FHIV).\n* Other neurodegenerative\u002Fautoimmune disease.\n* Patients not able to give written consent\n* Vulnerable patients such as children, pregnant women and prisoners","65 Years",{"count":121,"type":21},106,"OBSERVATIONAL","The investigators hypothesize that hypogammaglobulinemia (defined as IgG serum concentration \\\u003C7.0g\u002FL) is a treatable cause of fatigue in people with MS:\n\nThe primary objective is to prove the link between hypogammaglobulinemia and fatigue in patients with multiple sclerosis.\n\nThe secondary objective is to show that fatigue is mediated via frequent infections in people with MS and hypogammaglobulinemia.",[30,125,126],"Multiple Sclerosis","Fatigue",[126,30],"2026-04-30",{"date":130,"type":40},"2026-05-01",{"date":132,"type":40},"2022-07-01",{"date":134,"type":21},"2026-12-30",{"name":136,"class":137},"Insel Gruppe AG, University Hospital Bern","OTHER",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},"100591134","phase-2-study-of-igpro20-to-prevent-infection-in-people-with-multiple-myeloma-and-hypogammaglobulinemia-100591134","NCT06976476","Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia","Prospective Randomized Phase II Study Evaluating Efficacy and Safety of IgPro20 as Infection Prophylaxis in Patients With Multiple Myeloma and Hypogammaglobulinemia Receiving Therapy With a Bispecific Monoclonal Antibody (BsAbs)","Inclusion Criteria:\n\n* Diagnosis of RRMM receiving a commercially available bispecific antibody\n* Received at least 1 but no more than 4 cycles of BsAb\n* Males or females greater than or equal to 18 years old at the time of consent\n* ECOG ≤ 3\n* Life expectancy \\> 12 months\n\nExclusion Criteria:\n\n* HSCT within 3 months before enrollment\n* Planned CAR-T therapy in the next 6 months\n* \\>1 major (deep-seated) infection within the preceding 3 months\n* HIV infection, Active HCV, or Active HBV infection\n* Pregnancy\n* Neutrophils \\\u003C 500 x 10\\^9 per mL, Platelets \\\u003C 30 x 10\\^9 per mL\n* History of cancer other than MM in the last 3 years requiring active chemotherapy or radiation\n* Known reaction\u002Fallergy to IgG products\n* Intracranial hemorrhage or embolic CVA in the last 6 months\n* Hyperproteinemia\n* Protein-losing enteropathy\n* Creatinine Cl \\\u003C30 ml\u002Fmin\n* Documented progression on BsAb\n* Known history of Hyperprolinemia\n* On current or previous IVIG (in the last 3 months)",{"count":146,"type":21},100,[25],"The main purpose of this study is to see if IgPro20 can prevent infection in people with multiple myeloma (MM) who have hypogammaglobulinemia from receiving bispecific monoclonal antibodies (BsAbs).",[150,30,151],"Multiple Myeloma","Hypogammaglobulinemia, Acquired",[150,30,153,154,155],"IgPro20","Memorial Sloan Kettering Cancer Center","24-137","2026-03-10",{"date":158,"type":40},"2026-03-11",{"date":160,"type":40},"2025-05-08",{"date":162,"type":21},"2029-05-08",{"name":154,"class":137},8,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":198},"100491399","phase-2-role-of-antibiotic-therapy-or-immunoglobulin-on-infections-in-haematology-immunoglobulin-stopping-or-extension-100491399","NCT05678621","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension","A Randomised Controlled Trial of Continuing Immunoglobulin Therapy, or Stopping With or Without Prophylactic Antibiotics, on Infection Rate in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies.","RATIONALISE","Inclusion Criteria:\n\n1. Aged greater than or equal to 18 years of age\n2. Diagnosis of chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or non-Hodgkin lymphoma (NHL).\n3. Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for longer than 6 consecutive months.\n4. Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.\n5. Life expectancy greater than 12 months.\n6. Able to give informed consent, and willing and able to comply with each of the treatment arms.\n\nExclusion Criteria:\n\n1. Prior or planned allogeneic haematopoietic stem cell transplantation.\n2. Major infection (Grade 3 or higher) in preceding 3 months, and\u002For current active infection requiring antimicrobial treatment.\n3. Already receiving daily antibiotic prophylaxis for the purpose of preventing bacterial infection (Note: patients may receive antiviral, antifungal and Pneumocystis jirovecii pneumonia (PJP) prophylaxis).\n4. Intolerance of all trial antibiotic options in either arm A or arm B.\n5. Communication, compliance or logistical issues that are likely to limit patient's ability to take prophylactic or emergency antibiotics, or to obtain urgent medical attention for symptoms of infection.\n6. Pregnant or breastfeeding.\n7. Severe renal impairment (estimated or measured creatinine clearance of less than 30 mL\u002Fmin).\n8. Previous splenectomy.\n9. Previous participation in this trial.\n10. Treating team deems enrolment in the study is not in the best interests of the patient.",{"count":174,"type":21},300,[25,60],"The aim of the study is to find out if patients with blood cancers receiving immunoglobulin (Ig) for the purpose of preventing infections can safety stop immunoglobulin after six months of therapy, and take oral antibiotics instead to prevent serious infections.\n\nPatients may be eligible to join this study if they are aged 18 years or above, have an acquired hypogammaglobulinaemia secondary to a haematological malignancy, and have been receiving intravenous or subcutaneous Ig for longer than 6 consecutive months.\n\nParticipants will be randomised (allocated by chance) to one of three treatment groups, as follows:\n\n* Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to take every day (ARM A)\n* Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to keep at home to use as soon as symptoms of an infection develop (ARM B)\n* Continue receiving immunoglobulin (IVIg or SCIg) - this is the usual care group (ARM C)\n\nThe duration of each treatment is for 12 months from study entry.\n\nParticipants will be asked to attend a screening\u002Fbaseline visit so that their treating clinician can assess their eligibility for the trial and collect baseline data. If eligible for the trial, participants will then be randomly allocated to one of the three treatment groups.\n\nOnce randomised, active participation in the study will last for 13 months. During this period, participants will be asked to return to the hospital for a study visit every 3 months, with monthly telephone visits to check-in on your progress between each in-person visit. Participants will also be asked to complete a study diary, recording treatment compliance and signs\u002Fsymptoms of infection experienced throughout the study period.\n\nTypes of assessments and data collected will include: Medical history, demographics, physical examination, blood tests, stool sample, quality of life questionnaires, information about your general health, hospitalisations, medications and procedures. In order to assess and compare the cost-effectiveness of the treatment groups, the study team will also request authorisation from participants to access their Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), and Australian Immunisation Register (AIR) data.",[178,30],"Haematological Malignancy",[180,181,182,183,184,185,186,187,188],"Myeloma","Lymphoma","Leukaemia","Blood cancer","Malignancy","Infection","Antibiotic","Anti-infective agent","Immunoglobulin","2024-04-17",{"date":191,"type":40},"2024-04-19",{"date":193,"type":40},"2022-11-30",{"date":195,"type":21},"2027-04",{"name":197,"class":137},"Monash University",7]