Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating mantle cell lymphoma.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy 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, Vincritine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/VAM) in Patients With Previously Untreaded Mantle Cell Lymphoma|
- Progression-free survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
G-CSF 480 mcg SQ starting on day 12 (Cycle 1), day 7 (Cycle 2), day 13 (Cycle 3), day 7 (Cycle 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, Day 1 - for 4 Cycles and 200 mg/m2 IV, Days 2 - 5 for 4 Cycles
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 and combination chemotherapy comprising methotrexate, doxorubicin hydrochloride, cyclophosphamide, leucovorin calcium, vincristine sulfate, ifosfamide, etoposide, and cytarabine.
- 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.
- Courses 1 and 3: Patients receive rituximab IV and doxorubicin hydrochloride IV on day 1; vincristine sulfate IV on days 1 and 8; cyclophosphamide IV over 30 minutes on days 1-5; methotrexate IV continuously over 24 hours on day 10; leucovorin calcium IV every 6 hours beginning beginning 36 hours after start of methotrexate infusion and continuing until methotrexate level is below 0.05 nM; and filgrastim (G-CSF) subcutaneously (SC) beginning on day 13 and continuing until blood counts recover.
- Courses 2 and 4: Patients receive rituximab IV on day 1; cytarabine IV over 3 hours every 12 hours on days 1 and 2; ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5; and G-CSF SC beginning on day 7 and continuing until blood counts recover.
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 monthly for 3 months, 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 Sylvester Comprehensive Cancer Center - Miami||Recruiting|
|Miami, Florida, United States, 33186|
|Contact: Izidore S. Lossos, MD 866-574-5124|
|Principal Investigator:||Izidore S. Lossos, MD||University of Miami|