Actively Recruiting

Phase 3
Age: 18Years - 55Years
All Genders
NCT06705062

Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin as Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation

Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-03-17

316

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

Sponsors

S

Shanghai Jiao Tong University School of Medicine

Lead Sponsor

S

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a multi-center randomized study to compare the reduced-dose of post-transplantation cyclophosphamide (PTCY) at 35mg.kg to standard dose at 50mg/kg combined with tacrolimus and post-engraftment low dose anti-thymoglobin (ATG) as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem cell transplantation from alternative donor.

CONDITIONS

Official Title

Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin as Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing allogeneic hematopoietic stem cell transplantation with matched unrelated or haplo-identical donor
  • Normal organ function including creatinine clearance 65 ml/min/1.73m2 or creatinine 62 mg/dL
  • Normal liver function with ALT and AST 62.5 times normal and total bilirubin 61.5 times normal
  • Normal pulmonary function with FEV1, FVC, and DLCO 60%
  • Normal cardiac function with ejection fraction 60%
  • ECOG performance status of 0 to 2
  • Life expectancy of at least 3 months
  • Informed consent provided
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Active hepatitis with HBV-DNA 651 �d7 10^3 copies/ml
  • Active infection requiring antibiotics
  • HIV infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ruijin hsopital

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

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Research Team

J

Jiong HU

CONTACT

L

Li-ning Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin as Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation | DecenTrialz