Hematologic Malignancies
Conditions
Keywords
Chronic Myeloid Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkins Lymphoma, Hodgkin's Disease, Myelodysplastic Syndromes, Myeloproliferative Disorder
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.
Interventions
DRUGFludarabine
35 mg/m2 IV/day x 5 days
DRUGBusulfan
.8 mg/kg IV Q6h x 8 doses
DRUGThymoglobulin
1.5 mg/kg/day x 3 days
RADIATIONTotal Body Irradiation
150 cGy for 2 days
BIOLOGICALUmbilical Cord Blood
Two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient.
Sponsors
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event Free Survival | 180 days | Number of subjects surviving with no events at 180 days post transplantation (Day 0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Graft-versus-host disease (GVHD) | 1 year | Number of patients that experience acute or chronic GVHD. |
| Time course for peripheral blood chimerism. | 56 days | Percent of patients with \>95% donor chimerism. |
| Incidence of secondary lymphoproliferative diseases | 6 months | Number of patients with secondary lymphoproliferative diseases. |
| Transplant Engraftment | Day 42 | Number of patients with successful UCB engraftment. |
| Incidence of serious infectious complications | 1 year | Number of patients experiencing serious infectious complications. |
| Overall Survivals | 60 months | Number of patient with overall event free survival and overall survival distributions. |
| Incidence of disease recurrence | Up to two years | Number of patients experience disease recurrence. |
Countries
United States
Outcome results
None listed