Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases
This clinical study will evaluate the feasibility of a purified CD34 peripheral blood progenitor cell (PBPC) transplants in patients with hematological malignancies.
The primary objectives of the study are to evaluate the recipient obtaining donor derived neutrophil engraftment and the incidence of acute graft versus host disease [GvHD] (grade III-IV).
Secondary objectives include assessments of recipient having donor derived platelet engraftment, incidence of graft failure and chronic GvHD, overall and disease free survival, clinical safety and device performance of the CliniMACS CD34 selection device.
|Leukemia Lymphoma||Procedure: Megadose of CD34 Selected Progenitor Cells Drug: Melphalan Drug: Thiotepa Drug: Fludarabine Drug: Rabbit ATG||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases|
- Number of Participants With Absolute Neutrophil Count Engraftment [ Time Frame: Day 0 up to Day 30 ]Absolute neutrophil engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Baseline to Day 30 post transplant.
|Study Start Date:||September 2001|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: CD34 PBPC
CD34 peripheral blood progenitor cell (PBPC) transplants in 3 groups: 1) HLA-matched Sibling Transplant Patients; 2) Unrelated Donor Transplant Patients; 3) Haplo Identical Transplant Patients. Preparative regimen is 140 mg/m^2 Melphalan on day -8, 10 mg/kg Thiotepa on day -7, 160 mg/m^2 Fludarabine over 4 days on days -6, -5, -4, -3 and 1.5 mg/kg of Rabbit ATG a day times 4 over 4 days on days -6, -5, -4, -3.
Procedure: Megadose of CD34 Selected Progenitor Cells
Haploidentical peripheral blood progenitor cell (PBPC) transplants on Day 0.Drug: Melphalan
140 mg/m^2 on day -8
Other Name: AlkeranDrug: Thiotepa
10 mg/kg on day -7Drug: Fludarabine
160 mg/m^2 over 4 days on days -6, -5, -4, -3
Other Names:Drug: Rabbit ATG
1.5 mg/kg of Rabbit ATG a day times 4 over 4 days on days -6, -5, -4, -3.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00038857
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Richard E. Champlin, MD||M.D. Anderson Cancer Center|