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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.
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.
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
- 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
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