Clinical trial · Interventional
Leflunomide to Prevent Cytomegalovirus Reactivation in Stem Cell Transplant Patients
Use of Leflunomide as Primary Prophylaxis Against Cytomegalovirus (CMV) Reactivation in Haploidentical Haematopoietic Stem Cell Transplant (HIT) - Single, Arm, Phase 2 Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leflunomide 20 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Leflunomide
- description
- 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.
- interventionNames
- Drug: Leflunomide 20 mg
Primary outcomes (1)
- measure
- Number of participants with clinically significant cytomegalovirus (CMV) infection
- timeFrame
- Through Day +180 post hematopoietic stem cell transplantation (HSCT).
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males or females undergoing Haplo-identical haematopoetic stem cell transplant. 2. Age ≥18yrs on the day of signing informed consent 3. Undetectable CMV from plasma sample in preceding 7 days 4. Patient who has WBC engraftment (ANC\>=500/cumm for 3 or more consecutive days). 5. Within 7 days of WBC engraftment 6. 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 7. Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent. Exclusion Criteria: 1. Known hypersensitivity to Leflunomide 2. History of clinically significant CMV reactivation in past 1 year 3. Patient is receiving/has received drug known to have anti CMV activity within in last 7 days \[Ganciclovir, valganciclovir, foscarnet, letermovir, acyclovir (at doses \>=3200 mg PO per day or \>=25 mg/kg IV per day), valacyclovir (at doses \&\>=3000 mg PO per day)\] 4. Inadequate renal function (creatinine clearance \<=30 ml/min) 5. Chronic active hepatitis B (HBsAg+ or any HBV DNA+), hepatitis C, or/and HIV 6. Any psychiatric condition that might limit the ability of the patient to comply with the protocol
References
Publications (29)
- RESULTPREVYMIS™ (letermovir) Whitehouse Station, NJ: Merck & Co., Inc.; 2017
- RESULTLjungman P, Boeckh M, Hirsch HH, Josephson F, Lundgren J, Nichols G, Pikis A, Razonable RR, Miller V, Griffiths PD; Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials. Clin Infect Dis. 2017 Jan 1;64(1):87-91. doi: 10.1093/cid/ciw668. Epub 2016 Sep 28. PMID 27682069
- RESULTFox R, Helfgott S (2021). Leflunomide. In St Clair EW (Ed.), UpToDate. https://www.uptodate.com/drug-interactions. Accessed June 01, 2023
- RESULTStrand V, Cohen S, Schiff M, Weaver A, Fleischmann R, Cannon G, Fox R, Moreland L, Olsen N, Furst D, Caldwell J, Kaine J, Sharp J, Hurley F, Loew-Friedrich I. Treatment of active rheumatoid arthritis with leflunomide compared with placebo and methotrexate. Leflunomide Rheumatoid Arthritis Investigators Group. Arch Intern Med. 1999 Nov 22;159(21):2542-50. doi: 10.1001/archinte.159.21.2542. PMID 10573044
- RESULTUS Department of Health and Human Services, National Institutes of Health, National Cancer Institute (2017) Common Terminology Criteria for Adverse Events (CTCAE) Version Study protocol Version -1.1 dated 22/02/2024 17 of 16 5.0 2017. https://ctep.cancer.gov/ protocolDevelopment/electronic_applications/docs/ CTCAE_v5_Quick_Reference_8.5x11.pdf. Accessed 01 May 2020
- RESULTMatthes-Martin S, Feuchtinger T, Shaw PJ, Engelhard D, Hirsch HH, Cordonnier C, Ljungman P; Fourth European Conference on Infections in Leukemia. European guidelines for diagnosis and treatment of adenovirus infection in leukemia and stem cell transplantation: summary of ECIL-4 (2011). Transpl Infect Dis. 2012 Dec;14(6):555-63. doi: 10.1111/tid.12022. Epub 2012 Nov 12. PMID 23146063
- RESULTLindemans CA, Leen AM, Boelens JJ. How I treat adenovirus in hematopoietic stem cell transplant recipients. Blood. 2010 Dec 16;116(25):5476-85. doi: 10.1182/blood-2010-04-259291. Epub 2010 Sep 13.