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Randomized Trial of Mobilized Blood/Marrow Versus Blood Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01617473
Recruitment Status : Withdrawn (patients' reluctance)
First Posted : June 12, 2012
Last Update Posted : September 29, 2016
Information provided by (Responsible Party):
Xiaojun Huang, 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

Condition or disease Intervention/treatment Phase
Leukemia Procedure: transplant with PBSCs Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Randomized Trial of Unmanipulated Mobilized Blood/Marrow Versus Blood Haploidentical Transplant With Standard-risk Leukemia
Study Start Date : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. incidence of engraftment [ Time Frame: 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 :
  1. incidence of non-relapse mortality [ Time Frame: 1 year ]
    number of participants with non-relapse mortality at 1 year

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Standard risk of Recipients of haploidentical stem cell transplantation with myeloablative conditioning regimens

Exclusion Criteria:

  • Active, uncontrolled infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01617473

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Peking University People'S Hospital
Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
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Principal Investigator: Xiao-Jun Huang, M.D. Peking University People's Hospital

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Responsible Party: Xiaojun Huang, chief of peking university institute of hematology, Peking University People's Hospital Identifier: NCT01617473     History of Changes
Other Study ID Numbers: PUPH IRB [2012] (27)
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Neoplasms by Histologic Type