A Myeloablative Conditioning Regimen Consisting of Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients With Hematological Malignancy
- Determine, preliminarily, the efficacy of double-unit umbilical cord blood (UCB)
transplantation (UCBT) in patients with hematologic malignancy.
- Determine the incidence and rate of donor-derived neutrophil and platelet recovery in
- Determine the contribution of each unit of UCB to initial and sustained engraftment in
- Determine the incidence and severity of acute graft-vs-host disease (GVHD) at 100 days
in these patients.
- Determine the incidence and severity of chronic GVHD at 1 year in these patients.
- Determine the incidence of treatment-related mortality at 100 and 180 days in these
- Determine the incidence of malignant relapse in these patients.
- Determine the incidence of serious infectious complications in these patients.
- Determine immune recovery after UCBT and correlate with serious infectious
complications in these patients.
- Determine the probabilities of overall and disease-free survival of these patients at 2
years after UCBT.
- Determine the performance of double-unit correlative laboratory studies and correlate
with engraftment of each unit in these patients.
- Myeloablative preparative regimen: Patients receive fludarabine phosphate IV over 30
minutes on days -7 to -5 and cyclophosphamide IV over 30-60 minutes on days -6 and -5.
Patients also undergo total-body irradiation 3 times daily on days -3 to -1 and twice
on day 0.
- Umbilical cord blood (UCB) transplantation: Patients receive UCB IV over 20-60 minutes
on day 0. Patients also receive filgrastim (G-CSF) IV or subcutaneously beginning on
day 1 and continuing until blood counts recover.
- Graft-vs-host (GVHD) prophylaxis: Patients receive cyclosporine IV over 2-4 hours or
orally every 8-12 hours on days -3 to 100 and mycophenolate mofetil IV or orally twice
daily on days -3 to 45.
Blood samples and bone marrow aspirates are collected at baseline and periodically during
and after completion of study treatment. Samples may be examined for engraftment, chimerism
analysis, cytogenetic analysis, recovery of natural killer cells, and immune recovery.
Lymphoid immunophenotyping and function is also determined.
UCB units are examined by flow cytometry and killer immunoglobulin-like receptor (KIR)
After completion of study therapy, patients are followed periodically for at least 2 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Overall and disease-free survival at 1 year
Juliet Barker, MBBS
Memorial Sloan-Kettering Cancer Center
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|