Leflunomide to prevent Cytomegalovirus infection in Bone marrow transplantation

A Pilot study of Leflunomide to prevent Cytomegalovirus (CMV) reactivation in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) - Not applicable

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/06/008872

Enrollment

Registered

2017-06-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- 1. Patients undergoing Haplo-identical stem cell transplantation (HHSCT) 2. Patients undergoing matched unrelated donor transplantation (MUD HSCT)

Interventions

Intervention1: Leflunomide: Leflunomide will be started between Day +15 to +21 once patient has achieved a stable engraftment characterized by ANC 500/mm3 on 2 separate occasions. Leflunomide dosing

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing Haplo-identical stem cell transplantation (HHSCT) 2. Patients undergoing matched unrelated donor transplantation (MUD HSCT) 3. Patients willing to sign informed consent 4. Patients > 2 years of age [willing to swallow oral tablets] 5. Patient should be CMV IgG + prior to HSCT. 6. Patients with stable engraftment [ANC >500/mm3 on 2 occasions 1 day apart]

Exclusion criteria

Exclusion criteria: 1.Patients undergoing matched sibling donor transplantation 2.Patients who are CMV IgG negative prior to HSCT 3.Patients who are unable to swallow tablets 4.Patients will liver function tests > 5 ULN [SGPT >200, SGOT >200, Total Billirubin > 2 mg%] post engraftment 5.Patients who have already reactivated CMV prior to initiation of leflunomide.

Design outcomes

Primary

Measure	Time frame
1.To study the incidence of clinically significant CMV reactivation (CMV copies 1000) in patients having leflunomide prophylaxisTimepoint: 21 DAYS, Post 2 weeks, 6 weeks	—

Secondary

Measure	Time frame
1.To study the incidence of CMV reactivation (any copy number) in patients having leflunomide prophylaxis. 2.To study the safety and tolerability of the drug when used as prophylaxis 3.To study the incidence of BK virus related HC in patients undergoing leflunomide prophylaxisTimepoint: If patients develop CMV reactivation, they will receive a combination of Ganciclovir and Leflunomide. We will check leflunomide levels after 2 weeks and then after 6 weeks to see if adequate levels are being achieved.	—

Measure

Time frame

1.To study the incidence of CMV reactivation (any copy number) in patients having leflunomide prophylaxis. 2.To study the safety and tolerability of the drug when used as prophylaxis 3.To study the incidence of BK virus related HC in patients undergoing leflunomide prophylaxisTimepoint: If patients develop CMV reactivation, they will receive a combination of Ganciclovir and Leflunomide. We will check leflunomide levels after 2 weeks and then after 6 weeks to see if adequate levels are being achieved.

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Countries

India

Contacts

Public ContactDr Biju George

Christian Medical College, Vellore

biju@cmcvellore.ac.in04162282352

Outcome results

None listed

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