R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: Rituximab; Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide; Ifosfamide; Leucovorin; Methotrexate; Thalidomide; Vincristine; Mesna; Filgrastim (G-CSF); Granisetron; Decadron
Intervention description: Rituximab 375 mg/m2 IV, Days 1 of all cycles; 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 2 grams/m2 IV every 12 hours x 4 doses, Days 1 and 2, Cycles 2 and 4.; Doxorubicin 45 mg/m2 IV bolus, Day 1, Cycles 1 and 3; Etoposide 60 mg/m2 IV daily x 5 days, Cycles 2 and 4; Ifosfamide 1.5 grams/m2 IV once a day (QD) x 5 days, Cycles 2 and 4; 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 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.; Maintenance therapy.; Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3.; Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4; G-CSF 480 mcg subcutaneous (SQ) starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4); Granisetron 1 mg IV on Day 1, Cycle 1 and 3; Decadron 10 mg IV on Day 1, Cycles 1 and 3
Intervention MeSH terms: Leucovorin; Cytarabine; Thalidomide; Cyclophosphamide; Ifosfamide; Rituximab; Doxorubicin; Methotrexate; Etoposide; Vincristine; Granisetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated, histologically confirmed mantle cell lymphoma.

          -  Measurable or evaluable disease.

          -  All stages are eligible.

          -  Age > 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.

          -  Adequate hepatic function:

               -  Bilirubin < 3 mg/dL.

               -  Transaminases (SGOT and/or SGPT) < than 2.5 times the upper limit of normal for
                  the institution, unless due to lymphomatous involvement.

          -  Serum creatinine < 1.5 mg/Dl.

          -  Ability to give informed consent.

          -  Women of childbearing potential must have a negative pregnancy test within 72 hours of
             entering into the study. Males and females must agree to use adequate birth control if
             conception is possible during the study. Women must avoid pregnancy and men avoid
             fathering children while in the study.

          -  Life expectancy greater than 6 months.

        Exclusion Criteria:

          -  Previous chemotherapy, immunotherapy or radiotherapy for this lymphoma

          -  Concurrent active malignancies, with the exception of in situ carcinoma of the cervix
             and basal cell carcinoma of the skin.

          -  Grade 3 or 4 cardiac failure and/or ejection fraction < 50.

          -  Psychological, familial, sociological or geographical conditions that do not permit
             treatment and/or medical follow-up required to comply with the study protocol.

          -  Patients with a known history of HIV or AIDS

          -  Presence of hepatitis or hepatitis B virus (HBV) infection

          -  Pregnant or breast-feeding women.

          -  Central nervous system (CNS) involvement