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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the therapeutic efficacy of rituximab, cyclophosphamide, vincristine sulfate,
           and prednisone with vs without liposome-encapsulated doxorubicin citrate, in terms of
           complete remission rate at 6 months, in vulnerable or frail elderly patients with stage
           II, III, or IV diffuse large B-cell non-Hodgkin lymphoma.

        -  To assess the safety of these regimens in these patients.

      Secondary

        -  To evaluate the progression-free survival, event-free survival, and overall survival
           rates at 6 and 24 months in patients treated with these regimens.

        -  To evaluate the overall response rate at 6 and 24 months in patients treated with these
           regimens.

        -  To evaluate the duration of complete remission in patients treated with these regimens.

        -  To evaluate the acute side effects (according to the International CTC scale) of these
           regimens in these patients.

        -  To evaluate the geriatric condition and quality of life of patients treated with these
           regimens.

      OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I (R-COP regimen): Patients receive rituximab IV, cyclophosphamide IV, and
           vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and
           filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment
           repeats every 21 days for at least 3 courses.

        -  Arm II (R-COPY regimen): Patients receive rituximab, cyclophosphamide, vincristine
           sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive
           liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days
           for at least 3 courses.

      After 3 courses of R-COP or R-COPY, patients undergo evaluation. Patients with disease
      progression or a response of < 25% are removed from the study. Patients with a response of ≥
      25% receive 3 more courses of R-COP or R-COPY, followed by rituximab IV alone on day 1 of
      courses 7 and 8 in the absence of disease progression or unacceptable toxicity.

      After the completion of chemotherapy, some patients may undergo radiotherapy.

      Patients complete quality of life and geriatric assessment questionnaires at baseline and
      periodically during study treatment.

      After completion of study treatment, patients are followed every 3 months for 1 year, every 6
      months for 2 years.
    

Intervention name(s): filgrastim; pegfilgrastim; rituximab; cyclophosphamide; liposome-encapsulated doxorubicin citrate; prednisone; vincristine sulfate
Intervention type(s): Biological; Biological; Biological; Drug; Drug; Drug; Drug
Intervention description(s): Given subcutaneously; Given subcutaneously; Given IV; Given IV; Given IV; Given orally; Given IV
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized non-comparative phase II trial
Masking: None (Open Label)
Primary purpose: Treatment
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