RecruitingPhase 2

Leflunomide to Prevent Cytomegalovirus Reactivation in Stem Cell Transplant Patients

India22 participantsStarted 2024-10-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).
. Within 7 days of WBC engraftment
. 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
. Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with clinically significant cytomegalovirus (CMV) infection

Timeframe: Through Day +180 post hematopoietic stem cell transplantation (HSCT).

Trial details

NCT IDNCT07709013

SponsorTata Memorial Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04

Contact for this trial

Lingaraj Nayak, MD, DM

91-9167294976 lingarajnayak86@gmail.com

View on ClinicalTrials.gov More Hematologic Malignancies trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).
. Within 7 days of WBC engraftment
. 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
. Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent.

Leflunomide to Prevent Cytomegalovirus Reactivation in Stem Cell Transplant Patients

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Leflunomide to Prevent Cytomegalovirus Reactivation in Stem Cell Transplant Patients

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria