Pilot Study of Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies
OBJECTIVES:
Primary
- Determine the safety and feasibility of performing donor umbilical cord blood
transplantation (UCBT) in patients with advanced hematologic malignancies, in terms of
> 80% engraftment rate at day 100 post-transplant and ≤ 50% transplant-related
mortality.
Secondary
- Determine the toxicity of a myeloablative preparative regimen comprising busulfan,
fludarabine, and etoposide prior to UCBT in these patients.
- Determine the neutrophil and platelet recovery in patients treated with this regimen.
- Determine the event-free and overall survival of patients treated with this regimen.
- Evaluate lineage-specific chimerism after UCBT and assess the contribution of each
individual cord blood unit to post-transplantation hematopoiesis in these patients.
- Determine the incidence, severity, and timing of acute and chronic graft-vs-host
disease in patients treated with this regimen.
OUTLINE: This is a pilot study.
- Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3,
busulfan IV over 2 hours 4 times daily on days -7 and -4, etoposide IV over 4 hours on
day -3, and anti-thymocyte globulin IV over 6 hours on days -2 and -1.
- Donor umbilical cord blood transplantation (UCBT): Patients undergo donor UCBT on day
0. Beginning on day 7, patients receive sargramostim (GM-CSF) IV or subcutaneously once
daily until blood counts recover.
- Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously over 24
hours or orally twice daily beginning on day -2 and continuing until day 180 followed
by a taper. Patients also receive oral prednisone twice daily on days 13-50 and then
once daily on days 50-60, followed by a rapid taper.
After completion of study treatment, patients are followed periodically for approximately 2
years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies
Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies, in terms of > 80% engraftment rate at day 100 post-transplant and ≤ 50% transplant-related mortality.
up to 24 months post-transplant
Yes
Thomas G. Martin, MD
Study Chair
University of California, San Francisco
United States: Federal Government
CDR0000463370
NCT00304018
October 2002
March 2009
Name | Location |
---|---|
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |