Phase II study for testing Leflunomide to Prevent Cytomegalovirus (CMV) 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 - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067949

Enrollment

Registered

2024-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C969- Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified Health Condition 2: Z949- Transplanted organ and tissue status, unspecified

Interventions

Intervention1: Leflunomide: 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 haplo-

Eligibility

Inclusion criteria

Inclusion criteria: - Males or females undergoing Haplo-identical haematopoetic stem cell transplant. -Undetectable CMV from plasma sample in preceding 7 days -Patient who has WBC engraftment ANC More than 500 per cu mm for 3 or more consecutive days. -Within 7 days of WBC engraftment -Adequate liver functions ALT or AST less than 5 times upper limit of normal and Bilirubin less than 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.

Exclusion criteria

Exclusion criteria: -Known hypersensitivity to Leflunomide -History of clinically significant CMV reactivation in past 1 year -Patient is receiving or has received drug known to have anti CMV activity within in last 7 days Ganciclovir, valganciclovir, foscarnet, letermovir, acyclovir at doses more than 3200 mg PO per day or more than 25 mg/kg IV per day), valacyclovir (at doses More than 3000 mg PO per day -Inadequate renal function creatinine clearance less than 30 ml per min -Chronic active hepatitis B (HBsAg+ or any HBV DNA+), hepatitis C, or/& HIV -Any psychiatric condition that might limit the ability of the patient to comply with the protocol

Design outcomes

Primary

Measure	Time frame
To determine the rate of clinically significant CMV infection on prophylactic leflunomide in haplo-HSCT patients till day+180 post HSCT Timepoint: 25 weeks	—

Secondary

Measure	Time frame
-To evaluate the safety of post-transplant leflunomide using -To evaluate the incidence of clinically significant BK virus reactivation in peripheral blood and urine till day+180 Clinically significant BK virus reactivation will be defined as per ECIL-6 guidelines as more than 107 copies more than 7 log 10 gEq per mL in urine and 103 copies more than 1000 gEq per mL in blood will be considered significant thresholds to define BK virus re-activation - To evaluate the incidence of grade III IV acute GVHD. Timepoint: 5 years	—

Measure

Time frame

-To evaluate the safety of post-transplant leflunomide using -To evaluate the incidence of clinically significant BK virus reactivation in peripheral blood and urine till day+180 Clinically significant BK virus reactivation will be defined as per ECIL-6 guidelines as more than 107 copies more than 7 log 10 gEq per mL in urine and 103 copies more than 1000 gEq per mL in blood will be considered significant thresholds to define BK virus re-activation - To evaluate the incidence of grade III IV acute GVHD. Timepoint: 5 years

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Countries

India

Contacts

Public ContactLingaraj Nayak

ACTREC Tata Memorial Centre

lingarajnayak86@gmail.com9167294976

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026