Randomized Trial of Mobilized Blood/Marrow Versus Blood Transplant
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Purpose
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
| Condition | Intervention |
|---|---|
|
Leukemia |
Procedure: transplant with PBSCs |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Randomized Trial of Unmanipulated Mobilized Blood/Marrow Versus Blood Haploidentical Transplant With Standard-risk Leukemia |
- incidence of engraftment [ Time Frame: paticipants will be followed for the duration of hospital stay,an expected average of 30 days ] [ Designated as safety issue: No ]number of participants with engraftment at 30d
- incidence of non-relapse mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]number of participants with non-relapse mortality at 1 year
| Estimated Enrollment: | 320 |
| Study Start Date: | December 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: procedure/surgery
transplant with G-CSF mobilized PBSCs
|
Procedure: transplant with PBSCs
mobilized PBSCs for 2 consecutive days
Other Name: G-CSF mobilized peripheral blood stem cells
|
|
No Intervention: other
no intervention after transplant with mobilized BMPB
|
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.
Eligibility| Ages Eligible for Study: | 2 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Standard risk of Recipients of haploidentical stem cell transplantation with myeloablative conditioning regimens
Exclusion Criteria:
- Active, uncontrolled infection
Contacts and Locations| Contact: Yu Wang, M.D. | 861088326666 ext 4952 | ywyw31720@yahoo.com.cn |
| China | |
| Peking University People'S Hospital | Not yet recruiting |
| Beijing, China, 100044 | |
| Contact: Yu Wang, M.D. 861088326666 ext 4952 ywyw31720@yahoo.com.cn | |
| Principal Investigator: | Xiao-Jun Huang, M.D. | Peking University People's Hospital |
More Information
No publications provided
| Responsible Party: | Xiaojun Huang, chief of peking university institute of hematology, Peking University People's Hospital |
| ClinicalTrials.gov Identifier: | NCT01617473 History of Changes |
| Other Study ID Numbers: | PUPH IRB [2012] (27) |
| Study First Received: | June 8, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | China: Ministry of Health |
Additional relevant MeSH terms:
|
Leukemia Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013