NCT01622556
Terminated
Phase 2
Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies
ConditionsHematologic Malignancies
Overview
- Phase
- Phase 2
- Intervention
- Fludarabine
- Conditions
- Hematologic Malignancies
- Sponsor
- University of Virginia
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Event Free Survival
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Amer Beitinjaneh, MD
Assistant Professor of Medicine, Medical Director Stem Cell Transplant Unit
University of Virginia
Eligibility Criteria
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
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.
Arms & Interventions
Reduced Intensity Conditioning with UCB Transplant
Intervention: Fludarabine
Reduced Intensity Conditioning with UCB Transplant
Intervention: Busulfan
Reduced Intensity Conditioning with UCB Transplant
Intervention: Thymoglobulin
Reduced Intensity Conditioning with UCB Transplant
Intervention: Total Body Irradiation
Reduced Intensity Conditioning with UCB Transplant
Intervention: Umbilical Cord Blood
Outcomes
Primary Outcomes
Event Free Survival
Time Frame: 180 days
Number of subjects surviving with no events at 180 days post transplantation (Day 0).
Secondary Outcomes
- Transplant Engraftment(Day 42)
- Incidence of Graft-versus-host disease (GVHD)(1 year)
- Time course for peripheral blood chimerism.(56 days)
- Incidence of secondary lymphoproliferative diseases(6 months)
- Incidence of disease recurrence(Up to two years)
- Incidence of serious infectious complications(1 year)
- Overall Survivals(60 months)
Study Sites (1)
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