Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match

Stopped early · Phase 2

Conditions studied: Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Hodgkins Disease, Non-Hodgkins Lymphoma, Aplastic Anemia, Multiple Myeloma, Myelodysplastic Syndrome

In brief

The purpose of this study is to evaluate the multi-lineage hematopoietic chimerism for unrelated umbilical cord blood (UCB) grafts pooled from two to three cord blood units. Also to evaluate the toxicity, and antitumor responses of pooled unrelated UCB transplants.

Key facts

Study ID

NCT01500161

Run by

Texas Oncology Cancer Center

People needed

1

Starts

2011-11-01

Expected to finish

2013-11-01

Last updated by the study team

2013-11-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients < 65 years with hematologic malignancies needing stem cell transplant but do not have HLA-matched sibling donor. Patients with the following diagnosis will be included:
• AML in first or subsequent complete or partial remissions
• ALL in first or subsequent complete or partial remissions
• CLL in second remission or more advanced disease
• CML who has failed tyrosine kinase inhibitors
• Hodgkin's disease who relapse after autologous transplant
• Non-Hodgkin's lymphoma who relapse after autologous transplant or NK-cell lymphoma in CR1
• Aplastic anemia patients
• Multiple myeloma in second remission or moer advanced disease, including those who have failed an autologous transplant
• Myelodysplastic syndrome in first or subsequent complete or partial remission
• Patients must have 6/6, 5/6 or 4/6 molecular matches from unrelated UCB donors. Matching will be done for A, B, and DR. Matching at DR will be confirmed by molecular typing.
• Patients must be documented to be HIV negative. Screening must have been performed within previous 6 months.
• Patients must be able to give written consent.

You may not qualify if…

• Patient is excluded if all of the Inclusion criteria above isn't met.

Where it is running

• Texas Oncology — Amarillo, Texas, United States

Full record on ClinicalTrials.gov

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