Rituximab and Combination Chemotherapy Followed By Thalidomide in Treating Patients With Previously Untreated Mantle Cell Lymphoma
RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide 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 thalidomide works in treating patients with previously untreated mantle cell lymphoma.
Drug: Filgrastim (G-CSF)
|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 (Maclo/Ivam) in Patients With Previously Untreated Mantle Cell Lymphoma|
- Progression-free survival at 6, 12, 18, and 24 months [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
|Experimental: MACLO IVAM||
Rituximab 375 mg/m2 IV, Days 1 of all cycles
Other Name: RituxanDrug: Cyclophosphamide
Cyclophosphamide 800 mg/m2 IV, Day 1, Cyclophosphamide 200 mg/m2 IV Days 2 - 5, Cycles 1 and 3. Cyclophosphamide will be given in 100 cc NS IV over 30 minutes.
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, Cycles 2 and 4
Other Name: VP16Drug: Ifosfamide
Ifosfamide 1.5 grams/m2 IV QD x 5 days, Cycles 2 and 4
Other Name: IfexDrug: Leucovorin
Leucovorin 180 mg/m2 IV beginning 36 hours after start of methotrexate infusion and then 12 mg/m2 IV every 6 hours until methotrexate level is below 0.01 nM. Day 10, Cycles 1 and 3.
Other Name: Folinic AcidDrug: Methotrexate
Methotrexate 1,200 mg/m2 in 250 cc D5W IV over 1 hour followed by Methotrexate 5,520 mg/m2 in 1,000 cc D5W by continuous infusion over 23 hours (240 mg/m2 every hour for 23 hours). Day 10, Cycles 1 and 3.
Other Name: amethopterinDrug: Thalidomide
Other Name: ThalomidDrug: Vincristine
Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3.
Other Name: OncovinDrug: Mesna
Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4
Other Name: MesnexDrug: Filgrastim (G-CSF)
G-CSF 480 mcg SQ starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4)
Other Name: NeupogenDrug: Granisetron
Granisetron 1 mg IV on Day 1, Cycle 1 and 3
Other Names:Drug: Decadron
Decadron 10 mg IV on Day 1, Cycles 1 and 3
- Determine the progression-free survival of patients with previously untreated mantle cell lymphoma treated rituximab in combination with methotrexate, doxorubicin, cyclophosphamide, leucovorin, vincristine, ifosfamide, etoposide, cytarabine and mesna (MACLO/IVAM) followed by thalidomide.
- Determine the overall survival of patients treated with this regimen.
- Determine the response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: During cycle 1, patients will receive rituximab IV, granisetron IV, decadron IV, doxorubicin IV bolus, vincristine IVP on day 1; cyclophosphamide IV on day 1-5; vincristine IVP on day 8; methotrexate IV, methotrexate by continuous infusion, then leucovorin IV until methotrexate level is below 0.01 nM on day 10. 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) reaches1,500/mm^3, 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 2-3 weeks later, patients receive another course of therapy as above.After cycle 4, patients in complete remission will take oral thalidomide until progression of disease. 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 annually thereafter or at study termination.
PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450801
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Izidore S. Lossos, MD||University of Miami Sylvester Comprehensive Cancer Center|