Haploid Allogeneic Transplant Using the CliniMACS System
To assess the proportion of patients with donor neutrophil engraftment within 30 days of allogeneic transplant. To assess the incidence of acute GvHD during the first 100 days after transplantation.
Acute Myelogenous Leukemia (AML) - Relapsed, Primary Refractory Disease or Poor Risk Factors
Chronic Myelogenous Leukemia (CML) - Accelerated or Second Chronic Phase
Myelodysplastic Syndrome (MDS) - High and Intermediate Risk
Non-Hodgkin's Lymphoma (NHL)
Chronic Lymphocytic Leukemia (CLL) - Refractory
Device: CliniMACS System
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Feasibility Study Evaluating Haploidentical Allogeneic Transplantation Using the CliniMACS System in Patients With Advanced Hematologic Malignancies|
- Neutrophil Engraftment [ Time Frame: 30 days post-transplant ] [ Designated as safety issue: Yes ]Number of subjects recovering neutrophils, assessed as 1st of 3 consecutive days on which ANC > 0.5x10e9/L
- Acute GvHD (Grade II-IV) [ Time Frame: within 100 days post-transplant ] [ Designated as safety issue: Yes ]Number of subjects with acute GvHD (grade II-IV) within 100 days post-transplant, per the Consensus Conference on Acute GvHD Grading (Przepiorka D, et al. Bone Marrow Transplantation. 1995. 15:825-828).
- Platelet Recovery [ Time Frame: 40 days ] [ Designated as safety issue: No ]Number of subjects recovering platelets to > 20x10e9/L, assessed on the 7th day unsupported by platelet transfusions
|Study Start Date:||November 2001|
|Study Completion Date:||February 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: Haploidentical Allogeneic Transplant Using CliniMACS System
The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
Device: CliniMACS System
The CliniMACS System is a cell selection device consisting of the following components:
Other Name: CliniMACS Cell Selection System
To assess the proportion of patients with donor neutrophil engraftment within 30 days of allogeneic transplant; assess the incidence of acute GvHD during the first 100 days after transplantation; and assess platelet engraftment, graft failure, chronic GvHD, clinical safety, and devise performance.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185679
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Ginna G Laport, MD||Stanford Cancer Institute|