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

Status

Withdrawn

Conditions

Intervention / Treatment

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

  • China
      • Beijing, China, 100044
        • Peking University People's Hospital

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
Experimental: procedure/surgery
transplant with G-CSF mobilized PBSCs
Procedure: transplant with PBSCs
mobilized PBSCs for 2 consecutive days
Other Names:
  • G-CSF mobilized peripheral blood stem cells
No Intervention: other
no intervention after transplant with mobilized BMPB

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
number of participants with engraftment at 30d
paticipants will be followed for the duration of hospital stay,an expected average of 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of non-relapse mortality
Time Frame: 1 year
number of participants with non-relapse mortality at 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

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.

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