Phase II study for testing Leflunomide to Prevent Cytomegalovirus (CMV) Reactivation in Stem Cell Transplant Patients
- Conditions
- Health Condition 1: C969- Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecifiedHealth Condition 2: Z949- Transplanted organ and tissue status, unspecified
- Registration Number
- CTRI/2024/05/067949
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
days.
-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
consent.
-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
protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method