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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00067002 |
Primary objective:
In a prospective, phase II randomized study, to evaluate the transplantation of two unmanipulated cord blood units ("double cord blood" transplant) versus one unmanipulated and one expanded cord blood unit ("expanded cord blood transplant") in patients with hematologic malignancies following high-dose or nonmyeloablative therapy:
Secondary objectives:
Condition | Intervention | Phase |
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Leukemia, Lymphocytic, Acute Leukemia, Myelocytic, Acute Leukemia, Myeloid, Chronic Lymphoma, Non-Hodgkin |
Procedure: Expanded allogeneic cord blood (CB) Procedure: One Unmanipulated and One Expanded Cord Blood Unit |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Trial of Unmanipulated Versus Expanded Cord Blood |
Estimated Enrollment: | 110 |
Study Start Date: | April 2003 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Two Unmanipulated Cord Blood units
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Procedure: Expanded allogeneic cord blood (CB)
Transplantation of Two Unmanipulated Cord Blood Units
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B: Experimental
One Unmanipulated and One Expanded Cord Blood Unit
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Procedure: One Unmanipulated and One Expanded Cord Blood Unit
Transplantation of One Unmanipulated and One Expanded Cord Blood Unit.
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Ages Eligible for Study: | 1 Month to 61 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marcos De Lima, MD | 713-792-8750 |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 770030 | |
Contact: Brenda Muriera, RN 713-745-1957 bmuriera@mdanderson.org | |
Contact: Patricia A Williams, RN 713 794-1634 | |
Principal Investigator: Marcos De Lima, MD | |
Sub-Investigator: Elizabeth Shpall, MD |
Principal Investigator: | Marcos De Lima, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Marcos de Lima, MD/Assoc. Professor ) |
Study ID Numbers: | ID02-407 |
Study First Received: | August 8, 2003 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00067002 |
Health Authority: | United States: Food and Drug Administration |
ALL Leukemia, Lymphocytic, Acute AML Leukemia, Myelocytic, Acute CML |
Leukemia, Myeloid, Chronic NHL Lymphoma, Non-Hodgkin double cord blood transplant expanded cord blood transplant |
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Acute |
Leukemia Lymphatic Diseases Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Bone Marrow Diseases Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |