drugset / Trial / NCT00041132
S0213 Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining rituximab with chemotherapy may kill more cancer cells. PURPOSE: Phase II pilot study to study the effectiveness of combining chemotherapy with rituximab in treating patients who have newly diagnosed mantle cell lymphoma.
Timeline
- Start
- 2002-09
- Primary completion
- 2007-11
- Completion
- 2011-06
Publications
- Results A multi center trial of hyperCVAD+rituxan in patients with newly diagnosed mantle cell lymphoma EM Epner; J Unger; T Miller; L Rimsza; C Spier; M LeBlanc; R Fisher. Blood 110(11):#387. (2007).
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 12 g | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Doxorubicin | Other / unclassified | 16.6 mg/m2 | Intravenous |
| Subject | Methotrexate | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 170 mg | Oral |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |