Overview

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

Status:
Terminated
Trial end date:
2013-11-01
Target enrollment:
0
Participant gender:
All
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 toxicity, and antitumor responses of pooled unrelated UCB transplants.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Texas Oncology Cancer Center
Treatments:
Busulfan
Carmustine
Clofarabine
Cytarabine
Etoposide
Etoposide phosphate
Fludarabine
Fludarabine phosphate
Melphalan
Vidarabine
Criteria
Inclusion Criteria:

- 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 Criteria:

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