Clinical trial NCT00387959
Conditions: Leukemia Lymphoma
Keywords: recurrent mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma B-cell chronic lymphocytic leukemia refractory chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma recurrent marginal zone lymphoma recurrent adult diffuse small cleaved cell lymphoma splenic marginal zone lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma noncontiguous stage II marginal zone lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse small cleaved cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II mantle cell lymphoma
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2006-07-01; Completion date: 2014-04-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

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.

Arms: arm 1: Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
Interventions: intervention 1: filgrastim intervention 2: rituximab intervention 3: cyclophosphamide intervention 4: cyclosporine intervention 5: fludarabine phosphate intervention 6: mycophenolate mofetil intervention 7: allogeneic hematopoietic stem cell transplantation intervention 8: umbilical cord blood transplantation intervention 9: total-body irradiation
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None

Protocol documents: