drugset / Trial / NCT00020943
Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
Phase 2
Completed
79 enrolled
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and rituximab with peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.
Timeline
- Start
- 2001-06
- Primary completion
- 2006-12
- Completion
- 2009-09
Publications
- Results Damon LE, Johnson JL, Niedzwiecki D, Cheson BD, Hurd DD, Bartlett NL, Lacasce AS, Blum KA, Byrd JC, Kelly M, Stock W, Linker CA, Canellos GP. Immunochemotherapy and autologous stem-cell transplantation for untreated patients with mantle-cell lymphoma: CALGB 59909. J Clin Oncol. 2009 Dec 20;27(36):6101-8. doi: 10.1200/JCO.2009.22.2554. Epub 2009 Nov 16.
- Results Hsi ED, Jung SH, Lai R, Johnson JL, Cook JR, Jones D, Devos S, Cheson BD, Damon LE, Said J. Ki67 and PIM1 expression predict outcome in mantle cell lymphoma treated with high dose therapy, stem cell transplantation and rituximab: a Cancer and Leukemia Group B 59909 correlative science study. Leuk Lymphoma. 2008 Nov;49(11):2081-90. doi: 10.1080/10428190802419640.
- Results Damon LE, Johnson J, Niedzwiecki D, et al.: Immuno-chemotherapy (IC) and autologous stem cell transplant (ASCT) for untreated patients (pts) with mantle cell lymphoma (MCL): CALGB 59909. [Abstract] Blood 108 (11): A-2737, 2006.
- Liu H, Johnson JL, Koval G, Malnassy G, Sher D, Damon LE, Hsi ED, Bucci DM, Linker CA, Cheson BD, Stock W. Detection of minimal residual disease following induction immunochemotherapy predicts progression free survival in mantle cell lymphoma: final results of CALGB 59909. Haematologica. 2012 Apr;97(4):579-85. doi: 10.3324/haematol.2011.050203. Epub 2011 Nov 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 100 mg/kg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 2000 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 40 mg/kg | Intravenous |
| Subject | Methotrexate | Small molecule | 300 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 100 mg/m2 | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | carmustine | Small molecule | 15 mg/kg | Intravenous |
| Background | Leucovorin | Small molecule | 10 mg/m2 | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Background | filgrastim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |