Clinical Trials Directory

Trials / Completed

CompletedNCT01696461

A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor

A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
127 (actual)
Sponsor
Center for International Blood and Marrow Transplant Research · Network
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This is a Phase II, open-label, two strata, multicenter, prospective study of plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor for this purpose.

Detailed description

The primary objective is to determine the proportion of donors whose cells can be successfully mobilized and collected with a sufficient CD34+ cell dose using plerixafor as the mobilizing agent, using an intention-to-treat analysis. Donor mobilization following plerixafor will be considered successful if ≥ 2.0x10e6 CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections. All donors receiving plerixafor will be included in the analysis of the primary objective based on the intention-to-treat principle.Recipients will be classified into one of the two strata, myeloablative or reduced intensity, according to his/her conditioning regimen. The target enrollment is 64 donor/recipient pairs, 32 pairs per stratum.

Conditions

Interventions

TypeNameDescription
DRUGPlerixafor

Timeline

Start date
2013-05-01
Primary completion
2016-08-01
Completion
2016-08-01
First posted
2012-10-01
Last updated
2023-09-14
Results posted
2023-09-14

Locations

12 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01696461. Inclusion in this directory is not an endorsement.