NCT01617473

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
3.3 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

June 8, 2012

Last Update Submit

September 27, 2016

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

  • incidence of engraftment

    number of participants with engraftment at 30d

    paticipants will be followed for the duration of hospital stay,an expected average of 30 days

Secondary Outcomes (1)

  • incidence of non-relapse mortality

    1 year

Study Arms (2)

procedure/surgery

EXPERIMENTAL

transplant with G-CSF mobilized PBSCs

Procedure: transplant with PBSCs

other

NO INTERVENTION

no intervention after transplant with mobilized BMPB

Interventions

transplant with PBSCsPROCEDURE

mobilized PBSCs for 2 consecutive days

Also known as: G-CSF mobilized peripheral blood stem cells
procedure/surgery

Eligibility Criteria

Age2 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Active, uncontrolled infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People'S Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

Leukemia

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Xiao-Jun Huang, M.D.

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of peking university institute of hematology

Study Record Dates

First Submitted

June 8, 2012

First Posted

June 12, 2012

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2017

Last Updated

September 29, 2016

Record last verified: 2016-09

Locations

CN(1)