Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Non-Myeloablative Preparative Regimen
OBJECTIVES:
Primary
- To estimate the probability of survival at 1 year in patients with advanced
hematological malignancies or other diseases treated with non-myeloablative unrelated
donor umbilical cord blood transplantation.
Secondary
- Six month non-relapse mortality.
- Chimerism at days 7, 14, 21, 28, 56, and 80, at 6 months, and at 1 and 2 years.
- To determine the incidence of neutrophil engraftment at day 42.
- To determine the incidence of platelet engraftment at 6 months.
- To determine the incidence of grade II-IV and III-IV acute graft-versus-host-disease
(GVHD) at day 100.
- To determine the incidence of chronic GVHD at 1 year.
- To determine the incidence of clinically significant infections at 6 months and at 1
and 2 years.
- To determine the probability of progression-free survival at 1 and 2 years.
- To determine the probability of survival at 2 years.
- To determine the incidence of relapse or disease progression at 1 and 2 years.
OUTLINE: Patients are stratified according to disease status and prior therapy (hematologic
malignancy or other disease that was treated with an autologous stem cell transplant or ≥ 2
courses of multiagent chemotherapy within the past 3 months vs hematologic malignancy or
other disease that was treated with an autologous stem cell transplant > 12 months ago or
with ≤ 1 course of multiagent chemotherapy or immunosuppressive chemotherapy within the past
3 months vs refractory leukemia or lymphoma for which patient was rendered aplastic either
by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy).
- Conditioning regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6
to -2 and cyclophosphamide IV on day -6. Patients also undergo total body irradiation
on day -1. Some patients also receive anti-thymocyte globulin IV on days -6 to -4.
- Umbilical cord blood transplantation (UCBT): Patients undergo UCBT on day 0.
- Immunosuppressive therapy (graft-versus-host disease prophylaxis): Patients receive
cyclosporine IV over 1 hour or orally (as tolerated) every 8 or 12 hours beginning on
day -3 and continuing for approximately 6 months. Patients also receive mycophenolate
mofetil IV every 8 hours on days -3 to 5 and then orally on days 6-30.
After completion of study treatment, patients are followed at 6 months and then annually
thereafter.
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Probability of survival at 1 year
1 year
No
Colleen Delaney, MD, MSC
Principal Investigator
Fred Hutchinson Cancer Research Center
United States: Federal Government
2012.00
NCT00719849
November 2005
December 2009
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |