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

NCT06705062 | Recruiting Phase 3

• 1 other identifier: PTCY-REDSTAR-2024
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

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

Allogeneic Hematopoietic Cell Transplant; Graft Versus Host Disease

Keywords

post-transplantation cyclophosphamide; prophylaxis; reduced dose; graft versus host disease

Outcome Measures

Primary Outcomes (1)

• 100-day II-IV acute GVHD

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

  100 day

Secondary Outcomes (8)

• 100-day acute GVHD

  100 day

• 100-day non-relapse mortality

  100 day

• 1-year chronic GVHD

  1 year

• 1-year moderate to severe chronic GVHD

  1 year

• 1-year NRM

  1 year

Study Arms (2)

Reduced dose of post-transplantation cyclophosphamide

EXPERIMENTAL

study group

Drug: reduced-dose PTCy

Standard-dose PTCy

ACTIVE COMPARATOR

Patients receiving standard dose of post-transplantation cyclophosphamide

Drug: Standard dose PTCY

Interventions

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.

Reduced dose of post-transplantation cyclophosphamide

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.

Standard-dose PTCy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator

Study Sites (1)

Ruijin hsopital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Jiong HU

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong HU

CONTACT

86-13764313546; hj10709@rjh.com.cn

Li-ning Wang

CONTACT

86-21-64370045

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Blood & Marrow Transplantation Center, Rui Jin Hospital

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: November 26, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CN (1)