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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00067002 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
A: Experimental
Two Unmanipulated Cord Blood units
|
Procedure: Expanded allogeneic cord blood (CB)
Transplantation of Two Unmanipulated Cord Blood Units
|
|
B: Experimental
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 1 Month to 61 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have two CB units available which are matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens.
Each cord must contain at least 1E7 total nucleated cells/Kg recipient body weight in the pre-thawed fraction.
Continuation to Criteria # 6: 4.Adequate major organ system function as demonstrated by:a. Left ventricular ejection function of at least 40%.
b.Pulmonary function test demonstrating a diffusion capacity of at least 50%. predicted (high-dose). c.Creatinine < 1.6 mg/dL. d.SGPT/bilirubin <= to 2.0 x normal (high-dose).
Performance score of at least 60% by Karnofsky or PS < 2 (ECOG) (age >= 12 years), or Lansky Play-Performance Scale (age <12 years). 3. Age >= 1 month <=50 years. 4. Organ function requirements: a. Left ventricular ejection function of at least 50%. b. Pulmonary function test demonstrating a diffusion capacity of at least 50% predicted. c. Creatinine < 1.6 mg/dL. d. SGPT <= 2.0 x normal.
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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: | January 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00067002 History of Changes |
| 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 Acute Lymphoblastic Leukemia |
|
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Acute |
Leukemia Lymphatic Diseases Neoplasms Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |