Leflunomide to Prevent Cytomegalovirus Reactivation in Stem Cell Transplant Patients

NCT07709013 | Recruiting Phase 2 DMC

• 1 other identifier: 901006
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief 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. 1.Does leflunomide prevent cytomegalovirus (CMV) related organ damage?
2. 2.Does leflunomide prevent a rise in cytomegalovirus (CMV) copy number to more than 2000 copies/ml?
3. 3.Does leflunomide prevent the need to start pre-emptive therapy for cytomegalovirus (CMV)?
4. 4.Is it safe to use in bone marrow transplant ( BMT) patients?
5. 5.Does leflunomide prevent other viral reactivations - like Adeno virus and BK virus?
6. 6.Does leflunomide affect the risk of acute graft-versus-host disease ( acute GVHD) after bone marrow transplant (BMT)?

Conditions

Hematologic Malignancies

Keywords

Cytomegalovirus (CMV) Reactivation; Leflunomide; haplo-HSCT; Haploidentical; Hematopoietic stem cell transplant

Outcome Measures

Primary Outcomes (1)

• Number of participants with clinically significant cytomegalovirus (CMV) infection

  Number of participants with clinically significant cytomegalovirus (CMV) infection through Day +180 after hematopoietic stem cell transplantation (HSCT). Clinically significant CMV infection is defined as the occurrence of one or more of the following: Cytomegalovirus (CMV) end-organ disease; Cytomegalovirus (CMV) viremia ≥2,000 copies/mL measured by the central laboratory; or Initiation of pre-emptive anti-CMV therapy at the investigator's discretion.

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

Secondary Outcomes (3)

• Number of participants with treatment-emergent adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

  Day+180 post transplant

• Number of participants with clinically significant BK virus reactivation

  Day+180 post transplant

• Number of participants with Grade III-IV acute graft-versus-host disease

  Day+180 post transplant

Study Arms (1)

Leflunomide

EXPERIMENTAL

This will be a single arm open label intervention study. Patients who undergo haploidentical transplant, within 7 days of engraftment, will receive leflunomide till day+180 post transplant or till patient is on systemic immunosuppression.

Drug: Leflunomide 20 mg

Interventions

Leflunomide 20 mg DRUG

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.

Leflunomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Chronic active hepatitis B (HBsAg+ or any HBV DNA+), hepatitis C, or/and HIV
• Any psychiatric condition that might limit the ability of the patient to comply with the protocol

Sponsors & Collaborators

• Tata Memorial Centre: lead
• Indian Council of Medical Research: collaborator

Study Sites (3)

Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre

Navi Mumbai, Maharashtra, 410210, India

RECRUITING

Advanced Centre for Treatment, Research and Education in Cancer

Navi Mumbai, Maharashtra, 410210, India

NOT YET RECRUITING

Advanced Centre for Treatment, Research and Education in Cancer

Navi Mumbai, Maharashtra, 410210, India

NOT YET RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Leflunomide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Lingaraj Nayak, MD, DM

CONTACT

91-9167294976; lingarajnayak86@gmail.com

Sumeet Mirgh, MD, DM

CONTACT

91-8130140245; drsumeetmirgh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medical Oncology

Model Details: Single-arm, Phase 2, prospective, interventional study.

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: July 16, 2026
• Study Start: October 18, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3)