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Randomized Trial of Mobilized Blood/Marrow Versus Blood Transplant

Randomized Trial of Unmanipulated Mobilized Blood/Marrow Versus Blood Haploidentical Transplant With Standard-risk Leukemia

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01617473
Enrollment
0
Registered
2012-06-12
Start date
2015-10-31
Completion date
2017-10-31
Last updated
2016-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

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

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.

Interventions

PROCEDUREtransplant with PBSCs

mobilized PBSCs for 2 consecutive days

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Active, uncontrolled infection

Design outcomes

Primary

MeasureTime frameDescription
incidence of engraftmentpaticipants will be followed for the duration of hospital stay,an expected average of 30 daysnumber of participants with engraftment at 30d

Secondary

MeasureTime frameDescription
incidence of non-relapse mortality1 yearnumber of participants with non-relapse mortality at 1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026