Haploid Allogeneic Transplant Using the CliniMACS System

Phase 2

Terminated

• Conditions: Chronic Lymphocytic Leukemia (CLL) - Refractory; 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)
• Interventions: Device: CliniMACS System

• Registration Number: NCT00185679
• Lead Sponsor: Ginna Laport

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2009-10
• Study Completion: 2010-02
• Status Verified: 2015-02
• Results First Submitted: 2015-02-26
• Results First Submitted QC: 2015-02-26
• Last Update Submitted: 2015-02-26
• Results First Posted: 2015-03-09
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Haploidentical Allogeneic Transplant Using CliniMACS System	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.

Primary Outcome Measures

Name	Time	Method
Neutrophil Engraftment	30 days post-transplant	Number of subjects recovering neutrophils, assessed as 1st of 3 consecutive days on which ANC \> 0.5x10e9/L

Secondary Outcome Measures

Name	Time	Method
Acute GvHD (Grade II-IV)	within 100 days post-transplant	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	40 days	Number of subjects recovering platelets to \> 20x10e9/L, assessed on the 7th day unsupported by platelet transfusions

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States