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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Survival at 1 Year After Transplantation
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
Intervention: filgrastim (Biological)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
Intervention: rituximab (Biological)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
Intervention: cyclophosphamide (Drug)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
Intervention: cyclosporine (Drug)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
Intervention: fludarabine phosphate (Drug)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
Intervention: mycophenolate mofetil (Drug)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
Intervention: allogeneic hematopoietic stem cell transplantation (Procedure)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
Intervention: umbilical cord blood transplantation (Procedure)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
Intervention: total-body irradiation (Radiation)
Outcomes
Primary Outcomes
Survival at 1 Year After Transplantation
Time Frame: 1 Year after transplant
The number of patients survival status 1 year after transplantation
Secondary Outcomes
No secondary outcomes reported