Health TrialsbyHealthPanel

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

ConditionsAllogeneic Hematopoietic Cell TransplantGraft Versus Host Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Pregnancies

active hepatitis (HBV-DNA≥1×103 copies/ml);

active infection require anti-biotics;

HIV infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

316 Participants
are divided into 2 treatment groups
Group A: Reduced dose of post-transplantation cyclophosphamideExperimental treatment 1 intervention
Group B: Standard-dose PTCyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

100-day II-IV acute GVHD

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

Time frame
100 day

Secondary outcomes

1

100-day acute GVHD

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

Time frame
100 day
2

100-day non-relapse mortality

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

Time frame
100 day
3

1-year chronic GVHD

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

Time frame
1 year
4

1-year moderate to severe chronic GVHD

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

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Collaborator

Source ClinicalTrials.gov
Apply now