Transplantation of Two Partially Matched Umbilical Cord Blood Units Following Reduced Intensity Conditioning to Enhance Engraftment and Limit Transplant-Related Mortality in Adults With Hematologic Malignancies
OBJECTIVES:
Primary
- To evaluate the 100-day transplant-related (non-relapse) mortality in patients with
hematologic malignancies undergoing reduced-intensity conditioning comprising
fludarabine phosphate, melphalan, and anti-thymocyte globulin followed by sequential
umbilical cord blood transplantation (UCBT) from 2 partially-matched unrelated donors.
Secondary
- To evaluate the 12-month transplant-related (non-relapse) mortality.
- To evaluate the days to neutrophil engraftment (ANC > 500/mm³).
- To evaluate the days to platelet engraftment (platelet count > 20,000/mm³
[unsupported]).
- To evaluate the risk of acute and chronic graft-vs-host disease.
- To evaluate percent donor chimerism contribution of each cord unit.
- To evaluate relapse rate.
- To evaluate disease-free and overall survival.
- To evaluate transfusion support needed for UCBT recipients.
OUTLINE:
- Conditioning regimen: Patients receive fludarabine phosphate IV over 30 minutes on days
-7 to -3, melphalan IV over 30-60 minutes on day -2, and anti-thymocyte globulin IV
over 4-6 hours on days -4 to -2.
- Transplantation: Patients undergo two sequential umbilical cord blood transplantations
on day 0.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV continuously
and then orally twice daily beginning on day -1 and continuing until day 60, followed
by a taper until day 180 in the absence of GVHD. Patients also receive mycophenolate
mofetil IV or orally twice daily beginning on day 0 and continuing until day 30,
followed by a taper until day 60 in the absence of GVHD.
After completion of study treatment, patients are followed periodically.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With 100 Day Transplant-related Mortality (TRM)
100 Day TRM is death within 100 days from transplant related complications
100 days
Yes
Scott R. Solomon, MD
Principal Investigator
Blood and Marrow Transplant Group of Georgia
United States: Federal Government
CDR0000632453
NCT00827099
June 2006
November 2009
Name | Location |
---|---|
Blood and Marrow Transplant Group of Georgia | Atlanta, Georgia 30342-1601 |