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
| NCT ID | NCT06705062 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Allogeneic Hematopoietic Cell Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 316 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 316 participants in total. It began in 2025-01-01 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. patients undergo allo-HSCT with matched unrelated donor or haplo-identical donor; 2. 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%); 3. ECOG: 0-2; 4. Life expectation ≥3 months; 5. Informed consent provided. Exclusion Criteria: 1. Pregnancies 2. active hepatitis (HBV-DNA≥1×103 copies/ml); 3. active infection require anti-biotics; 4. HIV infection
Contact & Investigator
Jiong HU
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT06705062 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Allogeneic Hematopoietic Cell Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06705062 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 316 participants.
Is NCT06705062 currently recruiting?
Yes, NCT06705062 is actively recruiting participants. Contact the research team at hj10709@rjh.com.cn for enrollment information.
Where is the NCT06705062 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06705062 clinical trial?
NCT06705062 is sponsored by Shanghai Jiao Tong University School of Medicine. The principal investigator is Jiong HU at Ruijin Hospital. The trial plans to enroll 316 participants.