Randomized Trial of Mobilized Blood/Marrow Versus Blood Transplant

NCT ID: NCT01617473

Last Updated: 2016-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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procedure/surgery

transplant with G-CSF mobilized PBSCs

Group Type EXPERIMENTAL

transplant with PBSCs

Intervention Type PROCEDURE

mobilized PBSCs for 2 consecutive days

other

no intervention after transplant with mobilized BMPB

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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transplant with PBSCs

mobilized PBSCs for 2 consecutive days

Intervention Type PROCEDURE

Other Intervention Names

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G-CSF mobilized peripheral blood stem cells

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Active, uncontrolled infection
Minimum Eligible Age

2 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaojun Huang

chief of peking university institute of hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiao-Jun Huang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People'S Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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PUPH IRB [2012] (27)

Identifier Type: -

Identifier Source: org_study_id

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