This trial is active, not recruiting.

Condition lymphoma
Treatments rituximab, cyclophosphamide, cytarabine, doxorubicin, etoposide, ifosfamide, leucovorin, methotrexate, thalidomide, vincristine, mesna, filgrastim (g-csf), granisetron, decadron
Phase phase 2
Target CD20
Sponsor University of Miami
Start date April 2004
End date April 2015
Trial size 22 participants
Trial identifier NCT00450801, 20030165, SCCC-2003027, WIRB-20051242


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
rituximab Rituxan
Rituximab 375 mg/m2 IV, Days 1 of all cycles
cyclophosphamide Cytoxan
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.
cytarabine AraC
Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, Days 1 and 2, Cycles 2 and 4.
doxorubicin Adriamycin
Doxorubicin 45 mg/m2 IV bolus, Day 1, Cycles 1 and 3
etoposide VP16
Etoposide 60 mg/m2 IV daily x 5 days, Cycles 2 and 4
ifosfamide Ifex
Ifosfamide 1.5 grams/m2 IV QD x 5 days, Cycles 2 and 4
leucovorin Folinic Acid
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.
methotrexate amethopterin
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.
thalidomide Thalomid
Maintenance therapy.
vincristine Oncovin
Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3.
mesna Mesnex
Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4
filgrastim (g-csf) Neupogen
G-CSF 480 mcg SQ starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4)
granisetron Sancuso
Granisetron 1 mg IV on Day 1, Cycle 1 and 3
decadron Maxidex
Decadron 10 mg IV on Day 1, Cycles 1 and 3

Primary Outcomes

Progression-free survival at 6, 12, 18, and 24 months
time frame: 6, 12, 18, and 24 months

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

Inclusion Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed mantle cell lymphoma - All stages allowed - Previously untreated disease - Measurable or evaluable disease - No CNS involvement PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy > 6 months - Bilirubin < 3 mg/dL - SGOT and/or SGPT < 2.5 times upper limit of normal (unless due to lymphomatous involvement) - Creatinine < 1.5 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double-method contraception during and for ≥ 4 weeks after completion of study treatment (if receiving thalidomide) - No other concurrent active malignancies, except for in situ carcinoma of the cervix or basal cell carcinoma of the skin Exclusion Criteria: Grade 3-4 cardiac failure - LVEF that is less than ≥ 50% - psychological, familial, sociological, or geographical conditions that would preclude study compliance - known history of HIV or AIDS - hepatitis or hepatitis B virus infection PRIOR CONCURRENT THERAPY: - Any prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma

Additional Information

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
Description OBJECTIVES: Primary - 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. Secondary - 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by University of Miami.