Haplo-PBSC+Cord vs Haplo-PBSC+BM for Hematological Malignancies Undergoing Allo-HSCT (NCT05290545) | Clinical Trial Compass
CompletedPhase 3
Haplo-PBSC+Cord vs Haplo-PBSC+BM for Hematological Malignancies Undergoing Allo-HSCT
China314 participantsStarted 2022-02-15
Plain-language 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) transplantation.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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)
What they're measuring
1
Disease-free survival (DFS)
Timeframe: 1 year
Trial details
NCT IDNCT05290545
SponsorNanfang Hospital, Southern Medical University