S0349 Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Oblimersen in Treating Patients With Advanced Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Conditions

• 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

Eligibility Criteria

Sex

ALL

Age

19 Years - 59 Years

Healthy Volunteers

Not accepted

Interventions

• oblimersen sodium — BIOLOGICAL
  Given IV
• rituximab — BIOLOGICAL
  Given IV
• cyclophosphamide — DRUG
  Given IV
• doxorubicin hydrochloride — DRUG
  Given IV
• vincristine sulfate — DRUG
  Given IV
• prednisone — DRUG
  Given orally
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

This randomized phase II trial is studying rituximab and combination chemotherapy to see how well they work compared to oblimersen, rituximab, and combination chemotherapy in treating patients with advanced diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of anticancer drugs by making cancer cells more sensitive to the drugs. Combining rituximab and combination chemotherapy with oblimersen may kill more cancer cells

Key Dates

Start date

Mar 31, 2004

Status verified

Jan 2013

Primary completion

Jun 30, 2007

Study Design

Enrollment

160 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (closed to accrual as of 9/21/04)
  Patients receive rituximab IV over 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1 and oral prednisone on days 1-5.
• Experimental: Arm II
  Patients receive oblimersen IV continuously on days 1-7; rituximab IV over 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 5; and oral prednisone on days 5-10.

Primary Outcome Measure

1 year PFS [ Time Frame: At 1 year ]

Locations (1)

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