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Can a lower drug dose make stem cell transplants safer?

NCT ID NCT07719946

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial investigates whether giving a reduced dose of the drug cyclophosphamide after a half-matched stem cell transplant can prevent graft-versus-host disease (GVHD) while causing fewer side effects. The standard dose often leads to infections and slow immune recovery. Researchers will give 20 adults with blood cancers half the usual dose and monitor how well it controls GVHD and how quickly their immune system bounces back.

What this could mean

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

Active substance
a lower dose of the drug cyclophosphamide (25 mg/kg/day) given on days 3 and 4 after transplant
What this could lead to
If successful, this could make half-matched stem cell transplants safer by reducing infections and helping the immune system recover faster.
What could go wrong
This is a small, single-arm trial with only 20 participants and no comparison group. The lower dose may turn out to be less effective at preventing graft-versus-host disease.

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 20 people

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

Started

Mar 2025

Expected to finish

Nov 2028

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: - * Patients age ≥ 18 years * ECOG performance score of 0 or 1 Exclusion Criteria: - * Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. * Any medical or psychiatric illness which precludes the participant from giving informed consent. * Organ function criteria: Serious organ dysfunctions: * Serious cardiac dysfunction: Left ventricular ejection fraction \< 45%; no uncontrolled arrhythmias or symptomatic cardiac disease. * Serious pulmonary organ dysfunction: Symptomatic pulmonary disease; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLCO) =\< 50% of predicted (corrected for haemoglobin). * Serious renal dysfunction: Measured serum creatinine clearance =\< 60 mL/min. * Serious Hepatic dysfunction: Total serum bilirubin more than twice upper normal limit or Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3-fold higher than laboratory upper normal limits.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm

As listed by the trial registrant

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

Haploidentical hematopoietic stem cell transplant Hematological malignancies

How to take part

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

  1. The places running it

    2 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

    RECRUITING

    Navi Mumbai, Maharashtra, 410210, India

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