Clinical trial NCT00450801
Conditions: Lymphoma
Keywords: contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage I mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma
Sponsor: University of Miami
Start date: 2004-04-01; Completion date: 2015-07-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed 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 intravenous (IV), granisetron IV, decadron IV, doxorubicin IV bolus, vincristine intravenous pyelogram (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 nanomolar (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.

Arms: arm 1: Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
Interventions: intervention 1: Rituximab intervention 2: Cyclophosphamide intervention 3: Cytarabine intervention 4: Doxorubicin intervention 5: Etoposide intervention 6: Ifosfamide intervention 7: Leucovorin intervention 8: Methotrexate intervention 9: Thalidomide intervention 10: Vincristine intervention 11: Mesna intervention 12: Filgrastim (G-CSF) intervention 13: Granisetron intervention 14: Decadron
Intervention descriptions: intervention 1: Rituximab 375 mg/m2 IV, Days 1 of all cycles intervention 2: 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. intervention 3: Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, Days 1 and 2, Cycles 2 and 4. intervention 4: Doxorubicin 45 mg/m2 IV bolus, Day 1, Cycles 1 and 3 intervention 5: Etoposide 60 mg/m2 IV daily x 5 days, Cycles 2 and 4 intervention 6: Ifosfamide 1.5 grams/m2 IV once a day (QD) x 5 days, Cycles 2 and 4 intervention 7: 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. intervention 8: Methotrexate 1,200 mg/m2 in 250 cc 5 percent dextrose in water (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. intervention 9: Maintenance therapy. intervention 10: Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3. intervention 11: Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4 intervention 12: G-CSF 480 mcg subcutaneous (SQ) starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4) intervention 13: Granisetron 1 mg IV on Day 1, Cycle 1 and 3 intervention 14: Decadron 10 mg IV on Day 1, Cycles 1 and 3

Protocol documents: