Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Conditions
Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Mantle-Cell
Conditions: 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
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: G-CSF Type: Biological
Name: Rituximab Type: Drug
Name: Cyclophosphamide Type: Drug
Name: Cytarabine Type: Drug
Name: Doxorubicin Type: Drug
Name: Etoposide Type: Drug
Name: Ifosfamide Type: Drug
Name: Leucovorin Type: Drug
Name: Mesna Type: Drug
Name: Methotrexate Type: Drug
Name: Vincristine Type: Drug
Overall Status
Recruiting
Summary
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.
Detailed Description
OBJECTIVES:

Primary

- 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)

Secondary

- 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.

OUTLINE:

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 64 Years
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Histologically confirmed mantle cell lymphoma

- 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 SGPT < 2.5 times upper limit of normal (unless due to lymphomatous involvement)

- Serum creatinine < 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No grade 3-4 cardiac failure

- LVEF ≥ 50%

- No known history of HIV or AIDS

- No hepatitis or hepatitis B virus infection

- No other concurrent active malignancy, except carcinoma in situ of the cervix and basal cell carcinoma of the skin

- No psychological, familial, sociological, or geographical conditions that would prohibit treatment and/or medical follow-up required to comply with study protocol

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma
Location
University of Miami
Miami, Florida, United States
Status: Recruiting
Contact: Izidore S. Lossos, MD - 305-243-4785 - ilossos@med.miami.edu
Start Date
March 2009
Sponsors
University of Miami
Source
University of Miami
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page