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Recruiting 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

Phase III Interventional Allogeneic Hematopoietic Cell Transplant Graft Versus Host Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: reduced-dose PTCy, Standard dose PTCY.
Who it may be relevant to
Registry conditions: Allogeneic Hematopoietic Cell Transplant, Graft Versus Host Disease. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Detailed description

This is a multi-center randomized study in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) from alternative donors (9-10/10 matched unrelated donor or haplo-identical donors). The aim is to evaluate to the efficacy and feasibly of reduced-dose of PTCY at 35mg/kg as GVHD prophylaxis. Patients will be assigned to study group receiving PTCy at 35mg/kg on day +3 and +4 together with tacrolimus starting from day +5 and single dose anti-thymoglobin at 2.5mg/kg as GVHD prophylaxis or to the control group with standard dose of PTCY at 50mg/kg on day +3 and +4 with same dose of tacrolimus and ATG as the study group.

Interventions

  • Drug reduced-dose PTCy
    Patients receiving reduced dose of PTCy at 35mg.kg on day +3 and +4 together with tacrolimus starting from day+5 and single dose of anti-thymoglobin (ATG) 2.5mg/kg at 72 hours after documentation of neutrophil engraftment.
  • Drug Standard dose PTCY
    Patients receiving standard dose PTCy at 50mg/kg on day +3 and +4 with tacrolimus starting from day +5 and single dose of anti-thymoglobin at 2.5mg/kg 72 hours after documentation of neutrophil engraftment.

Primary outcome measures

  • 100-day II-IV acute GVHD [Time frame: 100 day]
Secondary outcome measures (8)
  • 100-day acute GVHD [Time frame: 100 day]
  • 100-day non-relapse mortality [Time frame: 100 day]
  • 1-year chronic GVHD [Time frame: 1 year]
  • 1-year moderate to severe chronic GVHD [Time frame: 1 year]
  • 1-year NRM [Time frame: 1 year]
  • 1-year cumulated incidence of relapse [Time frame: 1 year]
  • 1-year overall survival [Time frame: 1 year]
  • 1-year graft host disease free and relapse free survival [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • patients undergo allo-HSCT with matched unrelated donor or haplo-identical donor;
  • 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%);
  • ECOG: 0-2;
  • Life expectation ≥3 months;
  • Informed consent provided.

Exclusion criteria

  • Pregnancies
  • active hepatitis (HBV-DNA≥1×103 copies/ml);
  • active infection require anti-biotics;
  • HIV infection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Ruijin hsopital — Shanghai

Identifiers

NCT: NCT06705062 · PTCY-REDSTAR-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗