Ruijin hsopital
Shanghai, Shanghai Municipality, 200025, China
Location status: Recruiting
NCT Number: NCT06705062
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Phase 3
Shanghai, Shanghai Municipality, 200025, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 100 day
Patients diagnosed with grade II-IV acute GVHD within 100 day after allo-HSCT
Time frame: 100 day
Patients diagnosed with aGVHD of all grades within 100 days after allo-HSCT
Time frame: 100 day
Patients died of any causes without documentation of disease relapse or progression at day 100 after allo-HSCT
Time frame: 1 year
Patients diagnosed with chronic GVHD of all grades at 1 year after allo-HSCT
Time frame: 1 year
Patients diagnosed with moderate to severe chronic GVHD at 1 year after allo-HSCT
Time frame: 1 year
Patients died of any causes without documentation of relapse or disease progression 1 year after allo-HSCT
Time frame: 1 year
Patients died of relapse or disease progression 1 year after allo-HSCT
Time frame: 1 year
Patients remained alive at 1 year after allo-HSCT
Time frame: 1 year
Patients remained alive without relapse, grade III-IV aGVHD or moderate to severe chronic GVHD
Contact information is provided by the study sponsor or research team.
Shanghai Jiao Tong University School of Medicine
Other
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
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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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