Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with rituximab maintenance in patients with newly diagnosed mantle cell lymphoma
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by rituximab works in treating patients with previously untreated mantle cell lymphoma.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/VAM) in Patients With Previously Untreated Mantle Cell Lymphoma|
- Progression-free survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
G-CSF 480 mcg SQ starting on day 13 (Cycle 1, 3) and day 7 (Cycle 2, 4)
Other Names:Drug: Rituximab
375 mg/m2 IV according to standard protocol; Day 1 for 4 Cycles
Other Name: RituxanDrug: Cyclophosphamide
Cyclophosphamide 800 mg/m2 IV on Day 1 and 200 mg/m2 IV on Days 2 - 5 for Cycle 1, 3
Other Name: CytoxanDrug: Cytarabine
Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, days 1 and 2, Cycles 2 and 4
Other Name: AraCDrug: Doxorubicin
Doxorubicin 45 mg/m2 IV bolus Day 1 , Cycles 1 and 3
Other Name: AdriamycinDrug: Etoposide
Etoposide 60 mg/m2 IV daily x 5 days, Days 1 - 5, Cycles 2 and 4
Other Name: VP16Drug: Ifosfamide
Ifosfamide 1.5 grams/m2 IV QD x 5 days, Days 1 - 5, Cycles 2 and 4
Other Name: IfexDrug: Leucovorin
Leucovorin 100 mg/m2 IV beginning 36 hours after start of methotrexate infusion and then 10 mg/m2 IV every 6 hours until methotrexate level is below 0.05 nM. Day 10, Cycles 1 and 3.
Other Name: Folinic acidDrug: Mesna
Mesna 360 mg/m2 IV every 3 hours x 5 days, Days 1 - 5 Cycles 2 and 4
Other Name: MesnexDrug: Methotrexate
Methotrexate 1,200 mg/m2 in 250 mL D5W IV over 1 hour followed by Methotrexate 3,000 mg/m2 in 1,000 mL D5W by continuous infusion over 23 hours (130 mg/m2 every hour for 23 hours). Day 10 Cycles 1 and 3Drug: Vincristine
Vincristine 1.5 mg/m2 IVP (maximum of 2 mg) days 1 and 8 for Cycles 1 and 3
Other Name: Oncovin
- To evaluate progression-free survival of patients with previously untreated mantle cell lymphoma treated with rituximab in combination with methotrexate, doxorubicin, cyclophosphamide, leucovorin, vincristine, ifosfamide, etoposide, cytarabine and mesna (R-MACLO/IVAM)
- To evaluate overall survival of patients treated with this regimen.
- To evaluate the response rate in patients treated with this regimen.
- To evaluate the toxicity of this regimen in these patients.
Cycle 1, patients will receive rituximab IV, doxorubicin IV bolus, vincristine IVP on day 1; cyclophosphamide IV on day 1-5; vincristine IVP on day 8; methotrexate IV follow by methotrexate via continuous infusion on day 10, then leucovorin 100mg/m^2 IV, followed by leucovorin 10mg/m^2 IV until methotrexate level is below 0.01 nM on day 11. Patients will receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 13 and continuing until blood counts recover.
When absolute neutrophil count (ANC) reaches 1,500/mm^3 two consecutive times, patients will start cycle 2. Patients will receive rituximab IV on day 1; cytarabine IV on day 1 and 2; ifosfamide IV, mesna IV, etoposide IV on day 1-5; and G-CSF SC daily beginning on day 7 and continuing until ANC is greater than 1,000 cells/mm^3.
Approximately 7-14 days later, patients receive another course of therapy as above.
Patients who achieve complete remission after completion of course 4 receive rituximab IV once weekly for 4 weeks. Treatment repeats every 6 months for up to 3 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3-5 years, and then yearly thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878254
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33186|
|Contact: Izidore S. Lossos, MD 305-243-4785 email@example.com|
|Contact: University of Miami Sylvester Comprehensive Cancer Center 866-574-5124 firstname.lastname@example.org|
|Principal Investigator: Izidore S Lossos, MD|
|Principal Investigator:||Izidore S. Lossos, MD||University of Miami|