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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038857 |
Purpose
Donor:
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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Procedure: Megadose of CD34 Selected Progenitor Cells |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2001 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
Procedure: Megadose of CD34 Selected Progenitor Cells
Haploidentical peripheral blood progenitor cell (PBPC) transplants
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Richard E. Champlin, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T. M.D. Anderson Cancer Center ( Richard E. Champlin, MD/Professor ) |
| Study ID Numbers: | ID01-220 |
| Study First Received: | June 5, 2002 |
| Last Updated: | December 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00038857 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Myelodysplastic Syndrome Chronic Lymphocytic Leukemia Leukemia |
Lymphoma Non Hodgkin's Lymphoma T cell depletion CD34 selected progenitors cell GVHD |
|
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Myelodysplastic Syndromes Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphoma, Small Cleaved-cell, Diffuse Leukemia Lymphatic Diseases Chronic Lymphocytic Leukemia |
Acute Myelocytic Leukemia Preleukemia Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia |
|
Lymphatic Diseases Leukemia Neoplasms Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Lymphoproliferative Disorders Lymphoma |