se of Leflunomide as Primary Prophylaxis against Cytomegalovirus (CMV) Reactivation in Haploidentical Haematopoietic Stem Cell Transplant (HIT) Single arm Phase 2 Clinical Trial - NI

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•Males or females undergoing Haplo-identical haematopoetic stem cell transplant.
•-Undetectable CMV from plasma sample in preceding 7 days
•-Patient who has WBC engraftment ANC More than 500 per cu mm for 3 or more consecutive
•-Within 7 days of WBC engraftment
•-Adequate liver functions ALT or AST less than 5 times upper limit of normal and
•Bilirubin less than 3 times upper limit of normal at time of starting leflunomide
•-Understands the study procedures, alternative treatment available and risks involved
•with the study and voluntarily agree to participate by giving written informed

•-Known hypersensitivity to Leflunomide
•-History of clinically significant CMV reactivation in past 1 year
•-Patient is receiving or has received drug known to have anti CMV activity within in last
•7 days Ganciclovir, valganciclovir, foscarnet, letermovir, acyclovir at doses more than 3200
•mg PO per day or more than 25 mg/kg IV per day), valacyclovir (at doses More than 3000 mg PO per day
•-Inadequate renal function creatinine clearance less than 30 ml per min
•-Chronic active hepatitis B (HBsAg+ or any HBV DNA+), hepatitis C, or/& HIV
•-Any psychiatric condition that might limit the ability of the patient to comply with the

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