Loading clinical trials...
Loading clinical trials...
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
RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, total-body irradiation, and rituximab before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy together with rituximab and an umbilical cord blood transplant works in treating patients with B-cell non-Hodgkin's lymphoma.
OBJECTIVES: Primary * 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). Secondary * Determine the speed of neutrophil and platelet recovery post allograft in these patients. * 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 these patients. * Determine the incidence of malignant relapse or disease progression at 1 and 2 years in these patients. * Determine the probabilities of overall and event-free survival at 2 years after UCBT in these patients. * Determine the performance of laboratory studies investigating double-unit biology and correlate with unit engraftment in these patients. OUTLINE: * Pre-transplant rituximab therapy: Patients receive rituximab IV on days -8 or -7 and on day -4. * 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 28. * 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 taper. 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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Start Date
July 1, 2006
Primary Completion Date
April 1, 2014
Completion Date
April 1, 2014
Last Updated
February 1, 2016
17
ACTUAL participants
filgrastim
BIOLOGICAL
rituximab
BIOLOGICAL
cyclophosphamide
DRUG
cyclosporine
DRUG
fludarabine phosphate
DRUG
mycophenolate mofetil
DRUG
allogeneic hematopoietic stem cell transplantation
PROCEDURE
umbilical cord blood transplantation
PROCEDURE
total-body irradiation
RADIATION
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT00106925
NCT07388563
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions