Randomized Trial of Mobilized Blood/Marrow Versus Blood Transplant
- Conditions
- Leukemia
- Interventions
- Procedure: transplant with PBSCs
- Registration Number
- NCT01617473
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
The use of peripheral blood stem cells(PBSCs) is rapidly growing in the allogeneic transplantation setting as an alternative to bone marrow (BM).It was found that the use of PBSCs is associated with faster hematologic recovery but have yielded differing results regarding the incidence of graft-versus-host-disease (GVHD) and relapse.
The study hypothesis:
transplantation of mobilized PBSC to haploidentical donor with standard-risk leukemia had comparable engraftment and non-relapse mortality to mobilized BM combined with PBSCs
- Detailed Description
The donors were primed with granulocyte-colony stimulating factor (G-CSF) injected subcutaneously for five consecutive days. In the trial group, the PBSCs were harvested on the fourth and fifth day;in the control group, the bone marrow cells were harvested on the fourth day and the PBSCs were harvested on the fifth day.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Standard risk of Recipients of haploidentical stem cell transplantation with myeloablative conditioning regimens
- Active, uncontrolled infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description procedure/surgery transplant with PBSCs transplant with G-CSF mobilized PBSCs
- Primary Outcome Measures
Name Time Method incidence of engraftment paticipants will be followed for the duration of hospital stay,an expected average of 30 days number of participants with engraftment at 30d
- Secondary Outcome Measures
Name Time Method incidence of non-relapse mortality 1 year number of participants with non-relapse mortality at 1 year
Trial Locations
- Locations (1)
Peking University People'S Hospital
🇨🇳Beijing, China