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NCT Number: 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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ruijin hsopital

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

JIong HU

CONTACT

[email protected]

86-21-64370045 ext. 601878

JIong HU

PRINCIPAL_INVESTIGATOR

Li-ning Wang

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reduced-dose PTCy

Drug

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.

Standard dose PTCY

Drug

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 outcomes

  1. 100-day II-IV acute GVHD

    Time frame: 100 day

    Patients diagnosed with grade II-IV acute GVHD within 100 day after allo-HSCT

Secondary outcomes

  1. 100-day acute GVHD

    Time frame: 100 day

    Patients diagnosed with aGVHD of all grades within 100 days after allo-HSCT

  2. 100-day non-relapse mortality

    Time frame: 100 day

    Patients died of any causes without documentation of disease relapse or progression at day 100 after allo-HSCT

  3. 1-year chronic GVHD

    Time frame: 1 year

    Patients diagnosed with chronic GVHD of all grades at 1 year after allo-HSCT

  4. 1-year moderate to severe chronic GVHD

    Time frame: 1 year

    Patients diagnosed with moderate to severe chronic GVHD at 1 year after allo-HSCT

  5. 1-year NRM

    Time frame: 1 year

    Patients died of any causes without documentation of relapse or disease progression 1 year after allo-HSCT

  6. 1-year cumulated incidence of relapse

    Time frame: 1 year

    Patients died of relapse or disease progression 1 year after allo-HSCT

  7. 1-year overall survival

    Time frame: 1 year

    Patients remained alive at 1 year after allo-HSCT

  8. 1-year graft host disease free and relapse free survival

    Time frame: 1 year

    Patients remained alive without relapse, grade III-IV aGVHD or moderate to severe chronic GVHD

Study contacts

Contact information is provided by the study sponsor or research team.

Jiong HU

CONTACT

[email protected]

86-13764313546

Li-ning Wang

CONTACT

86-21-64370045

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 26, 2024
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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