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Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 55

Reduced versus standard dose post-transplant cyclophosphamide with tacrolimus and a single low-dose ATG to prevent GVHD after alternative-donor peripheral stem cell transplant

Official title: A Multi-center Randomized Clinical Study Comparing Reduced-dose (35mg/kg) Versus Standard Dose (50mg/kg) Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin (ATG) and Tacrolimus and Post-engraftment Anti-thymoglobin as Graft Versus Host Disease (GVHD) Prophylaxis in Patients Undergo Alternative Donor Peripheral Hematopoietic Stem Cell Transplantation

Run by Shanghai Jiao Tong University School of Medicine · NCT06705062 · Data updated 2026-11-12

This trial will see if a lower dose (35 mg/kg) of post-transplant cyclophosphamide plus tacrolimus and one low dose of ATG prevents graft-versus-host disease as well as the standard 50 mg/kg dose in patients receiving an allogeneic peripheral stem cell transplant from an unrelated or haploidentical donor.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment316 (estimated)
SponsorShanghai Jiao Tong University School of Medicine
Academic / other
Drugs / interventionscyclophosphamide
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedDecember 1, 2027
Study endsJuly 1, 2028
Registry record updatedMarch 17, 2026
Trial IDNCT06705062 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients undergoing allogeneic peripheral stem cell transplantation from a matched unrelated (9-10/10) or haploidentical donor who meet the trial's organ function (renal, hepatic, pulmonary, cardiac) and performance-status (ECOG 0-2) requirements and can provide informed consent.

Probably not a fit

Patients who are pregnant, have active hepatitis with high viral load, active infections requiring antibiotics, HIV infection, or inadequate organ function are excluded and therefore unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, phase 3, multicenter trial comparing reduced-dose post-transplantation cyclophosphamide (35 mg/kg on days +3 and +4) versus the standard dose (50 mg/kg on days +3 and +4) for graft-versus-host disease (GVHD) prophylaxis after alternative-donor peripheral stem cell transplantation. Both groups receive tacrolimus starting on day +5 and a single post-engraftment low dose of anti-thymocyte globulin (2.5 mg/kg). Eligible participants are patients receiving allo-HSCT from 9-10/10 matched unrelated or haploidentical donors who meet organ function and performance-status criteria. The trial is designed to compare feasibility and clinical outcomes related to GVHD prevention and post-transplant recovery between the two dosing strategies.

Why it matters

Potential benefit: If successful, the reduced PTCy dose could lower drug-related toxicity while maintaining protection against GVHD, potentially improving recovery after alternative-donor allo-HSCT.

How similar studies have gone: Post-transplant cyclophosphamide is an established GVHD prevention strategy and lower-dose approaches have been explored in smaller or nonrandomized studies, but large randomized phase 3 comparisons are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • Ruijin hsopital
    Shanghai, Shanghai Municipality, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Allogeneic Hematopoietic Cell Transplant 2Graft Versus Host Disease 63Cyclophosphamide 119Shanghai Jiao Tong University School of Medicine 60
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.