Pegfilgrastim and Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Aggressive B-Cell Non-Hodgkin Lymphoma

Sponsor
Universität des Saarlandes
Study ID
NCT00726700
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
61 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • pegfilgrastim — BIOLOGICAL
    Given subcutaneously
  • rituximab — BIOLOGICAL
    Given IV
  • cyclophosphamide — DRUG
    Given IV
  • doxorubicin hydrochloride — DRUG
    Given IV
  • prednisone — DRUG
    Given orally
  • vincristine sulfate — DRUG
    Given IV

Study Details

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. It is not yet known whether combination chemotherapy and pegfilgrastim is more effective when given with or without rituximab in treating non-Hodgkin lymphoma. PURPOSE: This phase II trial is studying the side effects of giving pegfilgrastim and combination chemotherapy together with or without rituximab and to see how well it works in treating older patients with aggressive B-cell non-Hodgkin lymphoma.

Key Dates

Start date
May 31, 2004
Status verified
Jul 2021
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

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

Arms

  • Active Comparator: Arm I (without rituximab)
    Patients receive pegfilgrastim subcutaneously (SC) on day 2 or 4 and CHOP comprising cyclophosphamide IV, doxorubicin IV, vincristine IV on day 1, and oral prednisone on days 1-5. Treatment repeats every 2 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (with rituximab)
    Patients receive pegfilgrastim and CHOP for up to 6-8 courses as in arm I. They also receive rituximab (administered 2 hours before beginning CHOP) on day 1. Treatment with rituximab repeats every 2 weeks for up to 8 courses.

Primary Outcome Measure

comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia [ Time Frame: through chemotherapy administration (up to 112 days respectively) ]

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