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Leflunomide to Prevent Cytomegalovirus Reactivation in Stem Cell Transplant Patients

RecruitingPhase 2Ages 18 Years - anyAllTata Memorial Centre
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In plain words

What the trial is, and whether it could suit you

Patients undergoing half-matched hematopoietic stem cell transplantation (HSCT) are at high risk of viral reactivation after bone marrow transplantation (BMT). The purpose of this study is to evaluate whether leflunomide can prevent cytomegalovirus (CMV) reactivation in these patients and to assess its safety. The main questions it aims to answer are - 1. Does leflunomide prevent cytomegalovirus (CMV) related organ damage? 2. Does leflunomide prevent a rise in cytomegalovirus (CMV) copy number to more than 2000 copies/ml? 3. Does leflunomide prevent the need to start pre-emptive therapy for cytomegalovirus (CMV)? 4. Is it safe to use in bone marrow transplant ( BMT) patients? 5. Does leflunomide prevent other viral reactivations - like Adeno virus and BK virus? 6. Does leflunomide affect the risk of acute graft-versus-host disease ( acute GVHD) after bone marrow transplant (BMT)? What

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Males or females undergoing Haplo-identical haematopoetic stem cell transplant. 2. Age โ‰ฅ18yrs on the day of signing informed consent 3. Undetectable CMV from plasma sample in preceding 7 days 4. Patient who has WBC engraftment (ANC\>=500/cumm for 3 or more consecutive days). 5. Within 7 days of WBC engraftment 6. Adequate liver functions (ALT / AST less than 5 times upper limit of normal and Bilirubin \<=3 times upper limit of normal) at time of starting leflunomide 7. Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent. Exclusion Criteria: 1. Known hypersensitivity to Leflunomide 2. History of clinically significant CMV reactivation in past 1 year 3. Patient is receiving/has received drug known to have anti CMV activity within in last 7 days \[Ganciclovir, valganciclovir, foscarnet, letermovir, acyclovir (at doses \>=3200 mg PO per day or \>=25 mg/kg IV per day), valacyclovir (at doses \&\>=3000 mg PO per day)\] 4. Inadequate renal function (creatinine clearance \<=30 ml/min) 5. Chronic active hepatitis B (HBsAg+ or any HBV DNA+), hepatitis C, or/and HIV 6. Any psychiatric condition that might limit the ability of the patient to comply with the protocol
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What it tests

  • Leflunomide 20 mg
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Where

3 sites
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre
Navi Mumbai, India
Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai, India
Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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