Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Randomized Trial of Mobilized Blood/Marrow Versus Blood Transplant

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Peking University People's Hospital
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01617473
First received: June 8, 2012
Last updated: January 2, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Active, uncontrolled infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617473

Contacts
Contact: Yu Wang, M.D. 861088326666 ext 4952 ywyw31720@yahoo.com.cn

Locations
China
Peking University People'S Hospital Not yet recruiting
Beijing, China, 100044
Contact: Yu Wang, M.D.    861088326666 ext 4952    ywyw31720@yahoo.com.cn   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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: January 2, 2014
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Leukemia
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 20, 2014