Clinical trial NCT00005803
Conditions: Prolymphocytic Leukemia Recurrent Adult Hodgkin Lymphoma Recurrent Childhood Hodgkin Lymphoma Recurrent Childhood Non-Hodgkin Lymphoma Recurrent Chronic Lymphocytic Leukemia Recurrent Non-Hodgkin Lymphoma Recurrent Small Lymphocytic Lymphoma Refractory Childhood Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Hodgkin Lymphoma Refractory Non-Hodgkin Lymphoma Refractory Small Lymphocytic Lymphoma T-Cell Chronic Lymphocytic Leukemia T-Cell Prolymphocytic Leukemia
Sponsor: Fred Hutchinson Cancer Center
Start date: 1999-09-01; Completion date: 2018-10-01
Enrollment: 76 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial studies how well autologous stem cell transplant followed by donor stem cell transplant works in treating patients with lymphoma that has returned or does not respond to treatment. Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate engraftment of human leukocyte antibody (HLA) identical peripheral blood stem cell (PBSC) allografts given after conditioning with total-body irradiation (TBI) (200cGy) +/- fludarabine (fludarabine phosphate), 90 mg/m\^2 and post-grafting immunosuppression with cyclosporine (CSP)/mycophenolate mofetil (MMF) in refractory or relapsed lymphoma patients following an initial autologous peripheral blood stem cell transplant (PBSCT) for disease cytoreduction.

II. To determine the non-relapse mortality at day 100 post-non-myeloablative allografting following mobilization and high-dose chemotherapy with autografting.

SECONDARY OBJECTIVES:

I. To determine the disease free survival and overall survival of non-myeloablative allografting following autologous PBSCT.

OUTLINE:

CONDITIONING REGIMEN: Patients with matched, related stem cell donors receive cyclophosphamide intravenously (IV) on days -6 and -5 and undergo TBI twice daily (BID) on days -3 to -1. Patients with matched, unrelated stem cell donors receive carmustine IV over 3 hours on day -7, etoposide IV over 2 hours BID on days -6 to -3, and cytarabine IV over 3 hours BID on days -6 to -3, and melphalan IV over 30 minutes on day -2.

TRANSPLANTATION: All patients undergo autologous PBSCT on day 0.

NON-MYELOABLATIVE CONDITIONING: Beginning 40-120 days following PBSC transplant, patients with related donors undergo TBI on day 0. Patients with unrelated donors receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.

TRANSPLANTATION: Patients undergo non-myeloablative allogeneic PBSCT on day 0.

IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) BID on days -3 to 56 (patients with related donors) or 100 (patients with unrelated donors) followed by taper to day 180. Patients also receive mycophenolate mofetil PO BID on days 0-27 (patients with related donors) or thrice daily (TID) on days 0-27, then BID on days 28-40 followed by taper to day 96 (patients with unrelated donors).

Some patients may undergo donor lymphocyte infusion if there is evidence of disease progression and no evidence of graft-vs-host disease (GVHD).

After completion of study treatment, patients are followed up at day 180, 1 year, 1.5 years, 2 years, 3 years, and then annually thereafter.

Arms: arm 1: See Detailed Description
Interventions: intervention 1: Autologous Hematopoietic Stem Cell Transplantation intervention 2: Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation intervention 3: Carmustine intervention 4: Cyclophosphamide intervention 5: Cyclosporine intervention 6: Cytarabine intervention 7: Etoposide intervention 8: Fludarabine Phosphate intervention 9: Laboratory Biomarker Analysis intervention 10: Melphalan intervention 11: Mycophenolate Mofetil intervention 12: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation intervention 13: Peripheral Blood Stem Cell Transplantation intervention 14: Therapeutic Autologous Lymphocytes intervention 15: Total-Body Irradiation
Intervention descriptions: intervention 1: Undergo autologous transplantation intervention 2: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation intervention 3: Given IV intervention 4: Given IV intervention 5: Given PO intervention 6: Given IV intervention 7: Given IV intervention 8: Given IV intervention 9: Correlative studies intervention 10: Given IV intervention 11: Given PO intervention 12: Undergo allogeneic transplantation intervention 13: Undergo allogeneic transplantation intervention 14: IV donor lymphocyte infusion intervention 15: Undergo radiotherapy

Protocol documents: