A Non-Myeloablative Conditioning Regimen With Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With B Cell Lymphoid Malignancies
- Determine the overall and event-free survival at 1 year in patients with B-cell
lymphoid malignancies treated with a nonmyeloablative conditioning regimen, rituximab,
and umbilical cord blood (UCB) transplantation (UCBT).
- Determine the speed of neutrophil and platelet recovery post allograft in these
- Determine the incidence and speed of donor-derived engraftment and contribution of each
UCB unit to engraftment in these patients.
- 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 serious infectious complications and correlate with
laboratory measurements of immune recovery in these patients.
- Determine the response to vaccination after UCBT in these patients.
- Determine the incidence of treatment-related mortality at 100 days and 180 days in
- Determine the incidence of malignant relapse or disease progression at 1 and 2 years in
- Determine the probabilities of overall and event-free survival at 2 years after UCBT in
- Determine the performance of laboratory studies investigating double-unit biology and
correlate with unit engraftment in these patients.
- Pre-transplant rituximab therapy: Patients receive rituximab IV on days -8 or -7 and on
- Nonmyeloablative conditioning regimen: Patients receive fludarabine phosphate IV over
30 minutes on days -6 to -2 and cyclophosphamide IV on day -6. Patients also undergo
total-body irradiation on day -1.
- Umbilical cord blood transplantation: Patients undergo umbilical cord blood
transplantation on day 0. Patients receive filgrastim (G-CSF) IV or subcutaneously
beginning on day 7 and continuing until blood counts recover.
- Post-transplant rituximab therapy: Patients receive rituximab IV on days 7, 14, 21, and
- Graft-vs-host disease prophylaxis: Patients receive cyclosporine IV over 2-4 hours or
orally twice daily on days -3 to 100, followed by a taper. Patients also receive
mycophenolate mofetil IV or orally three times daily on days -3 to 45, followed by a
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall and event-free survival at 1 year after transplantation
1 Year after transplant
Juliet Barker, MBBS
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|