OncoMatch/Clinical Trials/NCT07709013
Leflunomide to Prevent Cytomegalovirus Reactivation in Stem Cell Transplant Patients
Official title: Use of Leflunomide as Primary Prophylaxis Against Cytomegalovirus (CMV) Reactivation in Haploidentical Haematopoietic Stem Cell Transplant (HIT) - Single, Arm, Phase 2 Clinical Trial
Is NCT07709013 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies Leflunomide 20 mg for hematologic malignancies.
Treatment: Leflunomide 20 mg — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: CMV wild-type (absence)
Undetectable CMV from plasma sample in preceding 7 days
Lab requirements
Blood counts
WBC engraftment (ANC>=500/cumm for 3 or more consecutive days)
Kidney function
creatinine clearance >30 ml/min
Liver function
ALT / AST less than 5 times upper limit of normal and Bilirubin <=3 times upper limit of normal at time of starting leflunomide
WBC engraftment (ANC>=500/cumm for 3 or more consecutive days). ALT / AST less than 5 times upper limit of normal and Bilirubin <=3 times upper limit of normal. Inadequate renal function (creatinine clearance <=30 ml/min) [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07709013 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require CMV?
Yes, CMV wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify