Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: filgrastim; pegfilgrastim; rituximab; cyclophosphamide; liposome-encapsulated doxorubicin citrate; prednisone; vincristine sulfate
Intervention description: Given subcutaneously; Given subcutaneously; Given IV; Given IV; Given IV; Given orally; Given IV
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized non-comparative phase II trial
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 70 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma

Summary:

      RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such
      as cyclophosphamide, vincristine sulfate, prednisone, and liposome-encapsulated doxorubicin
      citrate, work in different ways to stop the growth of cancer cells, either by killing the
      cells or by stopping them from dividing. It is not yet known whether rituximab and
      combination chemotherapy are more effective when given together with or without
      liposome-encapsulated doxorubicin citrate in treating older patients with diffuse large
      B-cell non-Hodgkin lymphoma.

      PURPOSE: This randomized phase II trial is studying the side effects of giving rituximab
      together with cyclophosphamide, vincristine sulfate, and prednisone with or without
      liposome-encapsulated doxorubicin citrate and to see how well it works in treating older
      patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of diffuse large B-cell non-Hodgkin lymphoma

               -  Stage II, III, or IV disease (according to the WHO classification), including all
                  morphological and clinical variants

                    -  No Burkitt-like lymphoma (presence of small cells in the bone marrow biopsy
                       allowed)

               -  CD20+ disease

          -  Has ≥ 1 measurable target lesion ≥ 1.1 cm (according to the International Workshop
             Criteria)

          -  Poor physiological status, as defined by ≥ 1 of the following criteria:

               -  WHO performance status 3

               -  Clinical evaluation and measurement of LVEF that would preclude doxorubicin
                  administration (i.e., LVEF < 50%)

               -  Creatinine clearance < 50 mL/min

               -  Serum bilirubin > 30 μmol/L

               -  Severe comorbidity that would preclude the use of CHOP chemotherapy

          -  Ineligible for standard R-CHOP therapy

          -  No cerebral or meningeal involvement

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-3

          -  ANC > 750/mm^3

          -  Platelet count > 50,000/mm^3

          -  LVEF > 35%

          -  Able to receive either R-COP or R-COPY therapy

          -  No congestive heart failure, serious arrhythmia, or myocardial infarction within the
             past 6 months

          -  No other malignancy within the past 5 years except for adequately treated basal cell
             carcinoma of the skin or curatively treated carcinoma in situ of the cervix

          -  No active infection

          -  No active viral hepatitis B or C by serology

          -  No known HIV positivity

          -  No hypersensitivity to rituximab, any of its excipients, or to murine proteins

          -  No documented history of allergy to eggs or egg products

          -  No psychological, familial, sociological, or geographical condition that would
             preclude compliance with study treatment or follow-up schedule

        PRIOR CONCURRENT THERAPY:

          -  No prior therapy for this cancer

          -  No prior anthracycline administration with a cumulative dose > 240 mg/m² of
             doxorubicin hydrochloride or > 400 mg/m² of epirubicin hydrochloride

          -  More than 30 days since prior participation in another clinical trial involving
             investigational drugs

          -  No other concurrent antineoplastic agents