Randomized Trial of Mobilized Blood/Marrow Versus Blood Transplant
September 27, 2016 updated by: Xiaojun Huang, Peking University People's Hospital
Randomized Trial of Unmanipulated Mobilized Blood/Marrow Versus Blood Haploidentical Transplant With Standard-risk Leukemia
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
Study Overview
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100044
- Peking University People's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Standard risk of Recipients of haploidentical stem cell transplantation with myeloablative conditioning regimens
Exclusion Criteria:
- Active, uncontrolled infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: procedure/surgery
transplant with G-CSF mobilized PBSCs
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mobilized PBSCs for 2 consecutive days
Other Names:
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No Intervention: other
no intervention after transplant with mobilized BMPB
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of engraftment
Time Frame: paticipants will be followed for the duration of hospital stay,an expected average of 30 days
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number of participants with engraftment at 30d
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paticipants will be followed for the duration of hospital stay,an expected average of 30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of non-relapse mortality
Time Frame: 1 year
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number of participants with non-relapse mortality at 1 year
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiao-Jun Huang, M.D., Peking University People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Anticipated)
October 1, 2016
Study Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
June 8, 2012
First Submitted That Met QC Criteria
June 8, 2012
First Posted (Estimate)
June 12, 2012
Study Record Updates
Last Update Posted (Estimate)
September 29, 2016
Last Update Submitted That Met QC Criteria
September 27, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUPH IRB [2012] (27)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.