Status:
COMPLETED
Haplo-PBSC+Cord vs Haplo-PBSC+BM for Hematological Malignancies Undergoing Allo-HSCT
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
First Affiliated Hospital of Guangxi Medical University
Hunan Provincial People's Hospital
Conditions:
Hematological Malignancies
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The objective of this study was to explore whether the combination with umbilical cord blood (UCB) is associated with superior disease-free survival (DFS) in the setting of haploidentical donors (HID)...
Detailed Description
The main causes of allogeneic hematopoietic stem cell transplantation (allo-HSCT) failure are primary disease relapse and transplant-related complications, especially relapse. In recent years, with th...
Eligibility Criteria
Inclusion
- Patients with hematologic malignancies undergoing first HID allo-HSCT
- Age 18 to 65 years old with ECOG performance status 0-2
- Received myeloablative conditioning regimens
- Sign informed consent form, have the ability to comply with study and follow-up procedures
Exclusion
- Received PBSCs as only grafts
- Acute leukemia transformed from a myeloproliferative tumor
- Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
- Respiratory failure ( PaO2 ≤60mmHg)
- Hepatic abnormalities (total bilirubin ≥3 mg/dL, aminotransferase \>2 times the upper limit of normal)
- Renal dysfunction (creatinine clearance rate \< 30 mL/min)
- ECOG performance status 3, 4 or 5
- With any conditions not suitable for the trial (investigators' decision)
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2024
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT05290545
Start Date
February 15 2022
End Date
March 30 2024
Last Update
August 13 2024
Active Locations (1)
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1
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515