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Leflunomide to Prevent Cytomegalovirus Reactivation in Stem Cell Transplant Patients

NCT07709013 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-07-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Leflunomide 20 mg

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 haploidentical transplant or till patient is on systemic immunosuppression.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-18
Primary Completion
2029-04-30
Completion
2029-04-30

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07709013 on ClinicalTrials.gov