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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00067002 |
Purpose
The goal of this clinical research study is to learn if combining cord blood units to make the cells "take" faster in recipients will help to improve the results of cord blood transplants.
Objectives:
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:
a. To evaluate the rate, extent, and durability of hematopoietic reconstitution
Secondary objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: A
Two Unmanipulated Cord Blood units
|
Procedure: Expanded allogeneic cord blood (CB)
Transplantation of Two Unmanipulated Cord Blood Units
Other Name: double cord blood transplant
|
|
Experimental: B
One Unmanipulated and One Expanded Cord Blood Unit
|
Procedure: One Unmanipulated and One Expanded Cord Blood Unit
Transplantation of One Unmanipulated and One Expanded Cord Blood Unit.
Other Name: Expanded Cord Blood Transplant
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 1 Month to 61 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 770030 | |
| Principal Investigator: | Marcos De Lima, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00067002 History of Changes |
| Other Study ID Numbers: | ID02-407 |
| Study First Received: | August 8, 2003 |
| Last Updated: | October 4, 2011 |
| 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 Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |