Status:
TERMINATED
Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match
Lead Sponsor:
Texas Oncology Cancer Center
Conditions:
Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 toxic...
Detailed Description
Hematopoietic stem cell (HSC) transplantation, using human HLA-matched sibling or unrelated bone marrow or peripheral blood stem cell donor, has been used successfully to treat patients with high-risk...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patient is excluded if all of the Inclusion criteria above isn't met.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01500161
Start Date
November 1 2011
End Date
November 1 2013
Last Update
November 25 2013
Active Locations (1)
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1
Texas Oncology
Amarillo, Texas, United States, 79106