Clinical Trials Directory

Trials / Completed

CompletedNCT00005803

Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma

A Phase I/II Study of Autologous Stem Cell Transplantation Followed by Nonmyeloablative Allogeneic Stem Cell Transplantation for Patients With Relapsed or Refractory Lymphoma - A Multi-center Trial

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
76 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAutologous Hematopoietic Stem Cell TransplantationUndergo autologous transplantation
PROCEDUREAutologous-Allogeneic Tandem Hematopoietic Stem Cell TransplantationUndergo autologous-allogeneic tandem hematopoietic stem cell transplantation
DRUGCarmustineGiven IV
DRUGCyclophosphamideGiven IV
DRUGCyclosporineGiven PO
DRUGCytarabineGiven IV
DRUGEtoposideGiven IV
DRUGFludarabine PhosphateGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGMelphalanGiven IV
DRUGMycophenolate MofetilGiven PO
PROCEDURENonmyeloablative Allogeneic Hematopoietic Stem Cell TransplantationUndergo allogeneic transplantation
PROCEDUREPeripheral Blood Stem Cell TransplantationUndergo allogeneic transplantation
BIOLOGICALTherapeutic Autologous LymphocytesIV donor lymphocyte infusion
RADIATIONTotal-Body IrradiationUndergo radiotherapy

Timeline

Start date
1999-09-01
Primary completion
2016-01-01
Completion
2018-10-01
First posted
2003-01-27
Last updated
2020-01-29
Results posted
2017-12-07

Locations

5 sites across 2 countries: United States, Germany

Source: ClinicalTrials.gov record NCT00005803. Inclusion in this directory is not an endorsement.