Randomized Trial of Mobilized Blood/Marrow Versus Blood Transplant

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01617473
• Other study ID #: PUPH IRB [2012] (27)
• Status: Withdrawn
• Phase: N/A
• First received: June 8, 2012
• Last updated: September 27, 2016
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: September 2016
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Active, uncontrolled infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Leukemia

Intervention

Procedure:
• transplant with PBSCs
mobilized PBSCs for 2 consecutive days

Locations

Country	Name	City	State
China	Peking University People'S Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	incidence of non-relapse mortality	number of participants with non-relapse mortality at 1 year	1 year	Yes