Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies
Stopped early · Phase 2
Conditions studied: Hematologic Malignancies
In brief
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.
Key facts
- Study ID
- NCT01622556
- Run by
- University of Virginia
- People needed
- 6
- Starts
- 2012-01-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2014-02-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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