Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial

Sponsor
Institut Bergonié
Study ID
NCT00911183
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • filgrastim — BIOLOGICAL
    Given subcutaneously
  • pegfilgrastim — BIOLOGICAL
    Given subcutaneously
  • rituximab — BIOLOGICAL
    Given IV
  • cyclophosphamide — DRUG
    Given IV
  • liposome-encapsulated doxorubicin citrate — DRUG
    Given IV
  • prednisone — DRUG
    Given orally
  • vincristine sulfate — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Dec 2, 2008
Status verified
Mar 2022
Primary completion
Dec 31, 2012
Completion
Jan 1, 2015

Study Design

Enrollment
67 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Number of Participants in Complete Remission 6 Months After Randomization [ Time Frame: 6 months after randomization ]

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