Autologous Versus Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Patients With Chemosensitive Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response or First Partial Response (BMT CTN #0202)

NCT00096460 Phase 2/Phase 3 TERMINATED Results posted

This study is designed as a Phase II/III, multi-center trial, comparing two transplant strategies to determine whether non-myeloablative allogeneic Hematopoietic Stem Cell Transplantation (HSCT) will improve long-term progression-free survival compared to autologous HSCT. Recipients will be biologically assigned to the appropriate treatment arm depending on the availability of a Human Leukocyte Antigen (HLA) matched sibling.

Details

Lead sponsor	Medical College of Wisconsin
Phase	Phase 2/Phase 3
Status	TERMINATED
Enrolment	30
Start date	2004-08
Completion	2009-03

Conditions

• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma
• Recurrent Grade 3 Follicular Lymphoma
• Follicular Lymphoma

Interventions

• Cyclophosphamide and Rituximab
• Filgrastim
• Chemotherapy or Radiation therapy
• Non-myeloablative Conditioning regimen
• Allogeneic transplant
• Autologous transplant
• Rituximab maintenance therapy
• GVHD Prophylaxis

Primary outcomes

• Lymphoma Progression-free Survival — Three years post-Hematopoietic Stem Cell Transplant (HSCT)

Countries

United States