Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Fludarabine; Novantrone; Decadron; Rituximab; Interferon; Doxorubicin; Vincristine; Bleomycin; Cyclophosphamide; Etoposide; Cisplatin; Ara-C; Methyl-Prednisolone; Procarbazine; Prednisone
Intervention description: Group 1= 25 mg/m^2 IV over 15 min. Days 2 through 4 for 8 Cycles; Group 2 = 25 mg/m^2 IV over 15 min. Days 1 through 3 for 8 Cycles.; Group 1 = 10 mg/m^2 IV over 15 min. Day 2 for 8 Cycles; Group 2 = 10 mg/m^2 IV over 15 min. Day 1 for 8 Cycles; Group 3 = 10 mg/m^2 IV over 15 min. Day 2 of 3rd Sequence.; Group 1 = 20 mg IV over 15 min. Days 1 through 5 for 8 Cycles, then Days 1 through 3 Every Month for 1 Year; Group 2 = 20 mg IV over 15 min. Days 1 through 5 for 8 Cycles, then Days 1 through 3 Every Month for 1 Year; Group 3 = 40 mg PO Days 1 through 4 of 1st Sequence; After Completion of 3 Sequences, Days 1 through 3 Every Month for 1 Year.; Group 1 = 375 mg/m^2 IV Days 1 through 8 of Course 1, then Day 1 Only of Cycles 2 through 5; Group 2 = 4 Months after IFN Starts, 375 mg/m^2 IV Once Per Month for 6 Months; Group 3 = 375 mg/m^2 IV Days 1 through 8 of 1st Sequence; 375 mg/m^2 IV Days 1 through 8 of 3rd Sequence.; Group 1 = After Completion of Fludarabine, Novantrone, & Rituximab, IFN 3 mcg/ml/m^2 SQ Days 1 through 14 Each Month for 1 year; Group 2 = After Completion of Fludarabine & Novantrone, IFN 3 mcg/ml/m^2 SQ Days 1 through 14 Each Month for 1 year; Group 3 = After Completion of 3 Sequences, IFN 3 mcg/ml/m^2 SQ Days 1 through 14 Each Month for 1 year.; 25 mg/m^2 IV Days 2 & 3 of 1st Sequence.; .7 mg/m^2 IV Days 2 & 3 of 1st Sequence; 1.4 mg/m^2 IV Day 2 of 3rd Sequence.; 5 unit/m^2 IV Days 2 & 3 of 1st Sequence.; 750 mg/m^2 IV Day 2 of 1st Sequence.; 40 mg/m^2 IV Days 1 through 4 of 2nd Sequence.; 25 mg/m^2 IV Days 1 through 4 of 2nd Sequence; 1.5 gm/m^2 IV Day 5 of 2nd Sequence.; 500 mg IV Days 1 through 5 of 2nd Sequence.; 100 mg/m^2 PO Days 2 through 11 of 3rd Sequence.; 100 mg PO Days 1 through 5 of 3rd Sequence.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Dexamethasone; Prednisone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Cyclophosphamide; Rituximab; Doxorubicin; Fludarabine; Etoposide; Vincristine; Mitoxantrone; Bleomycin; Procarbazine; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 210.0
Sex: All
Maximum age: 76 Years
Healthy volunteers: No
Keywords: Lymphoma; Follicular Lymphoma; Indolent Lymphoma; Fludarabine; Novantrone; Mitoxantrone; Decadron; Dexamethasone; Rituximab; Anti-CD20; IDEC-C2B8; Chimeric Anti-CD20 Antibody; Interferon; Interferon Alpha-2b; IFN; Doxorubicin; Vincristine; Bleomycin; Cyclophosphamide; Etoposide; Cisplatin; Ara-C; Methyl-Prednisolone; Procarbazine; Prednisone; FND

Summary:

      The goal of this clinical research study is to compare chemotherapy given with rituximab to
      chemotherapy followed by rituximab. The safety of both treatment schedules will be studied.
      Laboratory tests of genetic changes in blood and bone marrow before and during the study will
      also be monitored.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Previously untreated stage IV indolent B-cell lymphoma [Amendment May 2001:
             eligibility restricted to follicular lymphoma]

          2. Age <76

        Exclusion Criteria:

        N/A