Leflunomide to Prevent Cytomegalovirus Reactivation in Stem Cell Transplant Patients
ConditionHematologic Malignancies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTata Memorial Centre
About this trial
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 medicine will the patients receive? Patients in study shall receive loading dose of Tab. Leflunomide 100 mg daily for 3 days followed by 20 mg daily orally. Leflunomide will be given till day +180 post transplant or till patient is on immunosuppressant medicines.
Eligibility criteria
Qualifiers
Males or females undergoing Haplo-identical haematopoetic stem cell transplant.
Age ≥18yrs on the day of signing informed consent
Undetectable CMV from plasma sample in preceding 7 days
Patient who has WBC engraftment (ANC>=500/cumm for 3 or more consecutive days).
Disqualifiers
Known hypersensitivity to Leflunomide
History of clinically significant CMV reactivation in past 1 year
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)]
Inadequate renal function (creatinine clearance <=30 ml/min)
Trial design
Treatments tested in this trial
- Leflunomide 20 mg
Treatment groups
22 Participants
are divided into 1 treatment groupSponsors and collaborators
Tata Memorial Centre
Lead sponsor
Indian Council of Medical Research
Collaborator
Source ClinicalTrials.gov