NCT01622556TerminatedPhase 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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- University of Virginia
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Event Free Survival
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Reduced Intensity Conditioning with UCB Transplant
Experimental
Intervention: Fludarabine (Drug)
Reduced Intensity Conditioning with UCB Transplant
Experimental
Intervention: Busulfan (Drug)
Reduced Intensity Conditioning with UCB Transplant
Experimental
Intervention: Thymoglobulin (Drug)
Reduced Intensity Conditioning with UCB Transplant
Experimental
Intervention: Total Body Irradiation (Radiation)
Reduced Intensity Conditioning with UCB Transplant
Experimental
Intervention: Umbilical Cord Blood (Biological)
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)
Investigators
Amer Beitinjaneh, MD
Assistant Professor of Medicine, Medical Director Stem Cell Transplant Unit
University of Virginia
Study Sites (1)
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