Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma

Sponsor
German High-Grade Non-Hodgkin's Lymphoma Study Group
Study ID
NCT00052936
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • filgrastim — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • CHOP regimen — DRUG
  • cyclophosphamide — DRUG
  • doxorubicin hydrochloride — DRUG
  • prednisone — DRUG
  • vincristine sulfate — DRUG
  • radiation therapy — RADIATION
    36Gy on BULK and extranodal involvement

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating aggressive non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying how well giving cyclophosphamide, doxorubicin, vincristine, and prednisone together with or without rituximab works in treating older patients who have aggressive non-Hodgkin's lymphoma. (This trial is no longer randomized as of 6/2005).

Key Dates

Start date
Jan 31, 2001
Status verified
May 2021
Primary completion
Aug 5, 2010
Completion
Aug 5, 2010

Study Design

Enrollment
1,506 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: S6
    6x CHOP-14
  • Experimental: R6
    6x CHOP-14 + 8x Rituximab
  • Experimental: S8
    8x CHOP-14
  • Experimental: R8
    8x CHOP-14 + 8x Rituximab

Primary Outcome Measure

Time to treatment failure at 3 years within the study and then periodically after study completion [ Time Frame: 3 years within the study and then periodically after study completion ]

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