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Leflunomide to Prevent Cytomegalovirus Reactivation in Stem Cell Transplant Patients

ConditionHematologic Malignancies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTata Memorial Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: LeflunomideExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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

Number of participants experiencing treatment-emergent adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Time frame
Day+180 post transplant
2

Number of participants with clinically significant BK virus reactivation

Number of participants with clinically significant BK virus reactivation through Day +180 after hematopoietic stem cell transplantation. Clinically significant BK virus reactivation is defined according to European Conference on Infections in Leukaemia (ECIL)-6 criteria as: Urine BK viral load \>10⁷ copies/mL (\>7 log₁₀ genome equivalents/mL), or Blood BK viral load \>10³ copies/mL (\>1,000 genome equivalents/mL).

Time frame
Day+180 post transplant
3

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

Number of participants who develop Grade III-IV acute graft-versus-host disease (aGVHD) according to the study-defined grading criteria.

Time frame
Day+180 post transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tata Memorial Centre

Lead sponsor

Indian Council of Medical Research

Collaborator

Source ClinicalTrials.gov
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