Rituximab and Combination Chemotherapy in Treating Older Patients With Previously Untreated B-Cell Lymphoma

Sponsor
German High-Grade Non-Hodgkin's Lymphoma Study Group
Study ID
NCT00290667
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • pegfilgrastim — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • cyclophosphamide — DRUG
  • doxorubicin hydrochloride — DRUG
  • prednisone — DRUG
  • vincristine sulfate — DRUG
  • pharmacological study — OTHER
  • radiation therapy — RADIATION

Study Details

RATIONALE: 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with previously untreated B-cell lymphoma.

Key Dates

Start date
Feb 29, 2004
Status verified
May 2021
Primary completion
Dec 31, 2013
Completion
Nov 30, 2015

Study Design

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

Arms

  • Active Comparator: Interventional: CHOP-14 + 8 x 2-weekly rituximab
    Arm I (2-weekly rituximab): Patients receive rituximab IV 375 mg/m\^2 (females) and 500 mg/m\^2 (males) over 4 hours on days 0, 14, 28, 42, 56, 70, 84, and 98. Patients also receive pegfilgrastim subcutaneously on day 4 of each course.
  • Active Comparator: Interventional: CHOP-14 + 8 x dose-dense rituximab
    Arm II (pharmacokinetic-based dose-dense rituximab): Patients receive rituximab IV 375 mg/m\^2 (females) and 500 mg/m\^2 (males) over 4 hours on days -1, 0, 3, 7, 14, 21, 28, and 42. Patients also receive pegfilgrastim subcutaneously on day 4 of each course.

Primary Outcome Measure

Pharmacokinetics (in first 20 patients of each cohort with a distinct variation of the rituximab schedule) assessed on days -4, -1, 10, 29, 57, 99, 155, 239, 267, 295, 407, and 491 of treatment [ Time Frame: -4 to 491 days of treatment ]

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