Bone Marrow Transplant Clinical Trials

Clinical trials related to Bone Marrow Transplant Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Ruijin hsopital
RECRUITING
Shanghai
Contact Information
Primary
Jiong HU
hj10709@rjh.com.cn
86-13764313546
Backup
Li-ning Wang
86-21-64370045
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 316
Treatments
Experimental: Reduced dose of post-transplantation cyclophosphamide
study group
Active_comparator: Standard-dose PTCy
Patients receiving standard dose of post-transplantation cyclophosphamide
Sponsors
Collaborators: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Leads: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov