Leflunomide to prevent CMV reactivation after haploidentical stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial evaluates leflunomide as a prophylactic agent to prevent cytomegalovirus (CMV) reactivation in adults receiving haploidentical HSCT for hematologic malignancies. Participants will receive a loading dose of leflunomide and are monitored for CMV-related organ damage, CMV viremia thresholds, need for pre-emptive antiviral therapy, safety, and other viral reactivations, as well as GVHD risk. The study addresses whether leflunomide can offer a cost-effective alternative in settings where standard antivirals are limited or expensive. Eligible patients are adults (≥18) undergoing haploidentical HSCT at Tata Memorial Centre ACTREC, Mumbai, with undetectable CMV and adequate liver function at baseline. Exclusions include known leflunomide allergy or recent CMV reactivation or antiviral use with CMV activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Males or females undergoing Haplo-identical haematopoetic stem cell transplant.
2. Age ≥18yrs 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

Where it's running

• Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre
  Navi Mumbai, Maharashtra, India Recruiting
• Advanced Centre for Treatment, Research and Education in Cancer
  Navi Mumbai, Maharashtra, India Not yet recruiting
• Advanced Centre for Treatment, Research and Education in Cancer
  Navi Mumbai, Maharashtra, India Not yet recruiting

Study contacts

• Study coordinator: Lingaraj Nayak, MD, DM
• Email: lingarajnayak86@gmail.com
• Phone: 91-9167294976

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.