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Could a common arthritis drug shield transplant patients from a dangerous virus?

NCT ID NCT07709013

Disease control Sponsor: Tata Memorial Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether leflunomide, a drug typically used for arthritis, can prevent cytomegalovirus (CMV) reactivation in adults with blood cancers who receive a half-matched stem cell transplant. Participants take leflunomide daily for up to six months after transplant. The study tracks how many develop significant CMV infections, organ damage, or need additional anti-CMV therapy, and monitors safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
leflunomide
What this could lead to
If effective, leflunomide could offer a new way to prevent dangerous CMV infections in stem cell transplant patients, reducing organ damage and the need for additional treatments.
What could go wrong
This is a small, early-phase trial with only 22 participants, so results may not apply broadly. Leflunomide may cause side effects or fail to prevent CMV reactivation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid system neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematologic malignancies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Centre for Treatment, Research and Education in Cancer

    NOT_YET_RECRUITING

    Navi Mumbai, Maharashtra, 410210, India

  • Advanced Centre for Treatment, Research and Education in Cancer

    NOT_YET_RECRUITING

    Navi Mumbai, Maharashtra, 410210, India

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

    RECRUITING

    Navi Mumbai, Maharashtra, 410210, India

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