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A Phase 2 Study in Poor Risk Diffuse Large B-cell Lymphoma of Total Lymphoid Irradiation & Antithymocyte Globulin Followed by Matched Allogeneic Hematopoietic Transplantation as Consolidation to Autologous Hematopoietic Cell Transplantation
The purpose of this study is to determine if double autologous then allogeneic hematopoietic cell transplant may offer an improved treatment option for patients with relapsed diffuse large B-cell lymphoma (DLBCL) who are not likely to be cured by the conventional transplantation regimen.
Details
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 3 |
| Start date | 2006-10 |
| Completion | 2010-05 |
Conditions
- Lymphoma, B-cell
- Lymphoma, Non-Hodgkin
- Diffuse Large B-cell Lymphoma (DLBCL)
- Malignant Lymphoma, Non-Hodgkin
Interventions
- Autologous hematopoietic stem cell transplantation (auto-HSCT)
- Allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Total lymphoid irradiation (TLI)
- Rituximab
- Carmustine
- Etoposide
- Filgrastim
- Anti-thymocyte globulin (ATG)
- Cyclosporine
- Mycophenolate mofetil (MMF)
Primary outcomes
- Event-free Survival (EFS) Per Protocol — 48 months
Event-free survival (EFS) through 4 years, as assessed in participants with poor-risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to HCT. Event is defined as tumor progression or death.
Countries
United States