Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma (MasterPlan)
Follicular lymphoma has historically been considered an incurable lymphoma. By combining multiple effective treatments, the investigators believe that prolonged disease-free survival is achievable in this disease. The investigators goal is to have at least 60-70% of our patients in first continuous complete remission 15 years from initiation of treatment.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Phase II Study Of Sequential Treatment With Chemotherapy, Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation in Patients With Follicular Lymphoma|
- Disease-free survival percentage(intention to treat) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Incidence of second malignancies [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||July 2026|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
C-MOPP-R chemotherapy, 6 cycles Peripheral blood stem cell mobilization Radioimmunotherapy Autologous Hematopoietic Stem Cell Transplantation
Other: Combination of treatment modalities
Intravenous cyclophosphamide, rituximab, and vincristine day 1 and 8 of 28 day cycles for 6 cycles total.
Oral prednisone and procarbazine day 1-14 of every 28 day cycle. Yttrium ibritumomab tiuxetan intravenous injection. Autologous stem cell transplant with intravenous BEAM (BCNU or carmustine, etoposide, ara-C or cytarabine, melphalan) chemotherapy conditioning.
Patients will receive six cycles of combination chemotherapy, C-MOPP-R, typically through a subcutaneous PORT. This combination chemotherapy will last six months. After the last dose of chemotherapy, patients will have a 2 month treatment holiday prior to undergoing stem cell mobilization from peripheral blood with subcutaneous injections of neupogen and mozobil. Patients then receive Zevalin radioimmunotherapy, and this is followed after recovery of blood counts, typically 3 months later, by an autologous stem cell transplant.
|Contact: Mark J Fesler, MDemail@example.com|
|Contact: Cindy Cantrell, RNfirstname.lastname@example.org|
|United States, Missouri|
|Saint Louis University Cancer Center||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Cindy Cantrell, RN 314-577-8854 email@example.com|
|Sub-Investigator: Mark J Fesler, MD|
|Principal Investigator: Paul J Petruska, MD|
|Principal Investigator:||Paul J Petruska, MD||St. Louis University|
|Study Director:||Mark J Fesler, MD||St. Louis University|