Pilot Study Of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning In Patients With Hematologic Disorders Or Severe Aplastic Anemia
OBJECTIVES:
- Determine the incidence and severity of acute toxicity in patients with hematologic
malignancies or severe aplastic anemia treated with a non-myeloablative conditioning
regimen followed by umbilical cord blood transplantation.
- Determine the incidence and severity of acute and chronic graft-versus-host-disease in
patients treated with this regimen.
- Determine the incidence of relapse, disease-free survival, and overall survival of
patients treated with this regimen.
- Determine the survival rate at 100 days post-transplantation in patients treated with
this regimen.
- Determine the incidence of regimen-related complications (infection, hepatic
veno-occlusive disease, and interstitial pneumonitis) in patients treated with this
regimen.
- Determine the incidence of primary and secondary graft failure in patients treated with
this regimen.
- Determine the rates and kinetics of donor-derived lymphoid, myeloid, neutrophil, RBC,
and platelet engraftment in patients treated with this regimen.
OUTLINE: Patients receive a non-myeloablative conditioning regimen comprising fludarabine IV
over 30 minutes on days -8 to -4, cyclophosphamide IV over 2 hours on days -3 to -2, and
anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1. Patients unable to
tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1.
Patients undergo multiple unit umbilical cord blood transplantation on days 0-1. Patients
receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood
counts recover.
Patients are followed monthly for 6 months; at 9, 12, 14, 16, 18, and 24 months; and then
annually thereafter.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Event-free survival by disease assessment
at 28 and 100 days and then at 6, 9, 12, 18, and 24 months
No
Brenda Cooper, MD
Principal Investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
CWRU6Y01
NCT00054236
May 2002
March 2011
Name | Location |
---|---|
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |