Can a lower drug dose prevent transplant complications just as well?

NCT ID NCT06705062

Disease control Sponsor: Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a lower dose of the drug cyclophosphamide can prevent graft-versus-host disease (GVHD) after stem cell transplants from unrelated or half-matched donors. About 316 participants will receive either a reduced dose (35 mg/kg) or the standard dose (50 mg/kg), along with other immune-suppressing drugs. The goal is to see if the lower dose works as well but causes fewer side effects.

What this could mean

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

Active substance: cyclophosphamide (reduced dose 35 mg/kg vs standard 50 mg/kg), tacrolimus, and anti-thymocyte globulin
What this could lead to: If successful, this could offer a safer way to prevent graft-versus-host disease after stem cell transplants, with fewer side effects and similar protection.
What could go wrong: This is a phase 3 trial, but the reduced dose may not prevent GVHD as well as the standard dose. Results may not apply to all transplant types or patient groups.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 316 people

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

Started

Jan 2025

Expected to finish

Jul 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 to 55 years

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. patients undergo allo-HSCT with matched unrelated donor or haplo-identical donor; 2. normal organ function (creatinine clearance ≥ 50ml/min/1.73m2 or creatinine ≤2mg/d(or 177μmol/L); no hepatic abnormal (ALT or AST≤2.5xN; TBil≤1.5XN); Normal pulmonary function (FEV1、 FVC、DLCO≥80%); normal cardiac function (EFS ≥50%); 3. ECOG: 0-2; 4. Life expectation ≥3 months; 5. Informed consent provided. Exclusion Criteria: 1. Pregnancies 2. active hepatitis (HBV-DNA≥1×103 copies/ml); 3. active infection require anti-biotics; 4. HIV infection

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Conditions

The condition(s) this trial relates to.

graft versus host disease prevention target

As listed by the trial registrant

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

Allogeneic hematopoietic cell transplant Graft versus host disease

How to take part

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

The places running it

1 site. The list below names each one and where it is.
The official record

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

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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.

Can a lower drug dose prevent transplant complications just as well?

What the study statuses mean