Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies
| Status: | Terminated |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/14/2017 |
| Start Date: | January 2012 |
| End Date: | January 2017 |
Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies
This is a phase II study to assess the day 180 event free and overall survival after
administration of a specified combination of fludarabine, busulfan, Total Body Irradiation
(TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant
in a single institution setting in patients with hematologic malignancies for whom allogeneic
transplantation is indicated.
administration of a specified combination of fludarabine, busulfan, Total Body Irradiation
(TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant
in a single institution setting in patients with hematologic malignancies for whom allogeneic
transplantation is indicated.
Inclusion Criteria:
Subjects 18-70 years old. ECOG 0-2
Patients must have a diagnosis of one of the following:
- Chronic Myeloid Leukemia
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Hodgkin's Disease
- Non-Hodgkins Lymphoma
- Myelodysplastic Syndromes
- Myeloproliferative Disorder
Patients must have adequate visceral organ function
- Patients must furnish written informed consent and HIPAA authorization for release of
personal health information.
- Patients must be able to understand the requirements of the study, abide by the study
restrictions, and agree to return for the required assessments.
Exclusion Criteria:
- Patients who have a histocompatible sibling-matched donor age 18 to 65 years in good
health who is willing to donate stem cells are ineligible.
- Patients who are pregnant are ineligible.
- Patients are ineligible if they have received cumulative chemotherapy doses in excess
of: carmustine (BCNU) 400 mg/m2, and/or a cumulative anthracycline exposure in excess
of 550 mg/m2 doxorubicin (Adriamycin®) unless gated-pool radionuclide cardiac scan
shows greater than/equal to 45% ejection fraction.
Patients who are HIV or HTLV-I, -II antibody sero-positive are ineligible.
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