Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• filgrastim — BIOLOGICAL
  Given subcutaneously or intravenous bolus.
• rituximab — BIOLOGICAL
  Given IV
• carboplatin — DRUG
  Given IV
• cyclophosphamide — DRUG
  Given IV
• doxorubicin hydrochloride — DRUG
  Given IV
• etoposide — DRUG
  Given IV
• ifosfamide — DRUG
  Given IV
• prednisone — DRUG
  Taken orally
• vincristine — 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 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 patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin's lymphoma.

Key Dates

Start date

Sep 26, 2006

Status verified

Jun 2023

Primary completion

Jun 30, 2013

Completion

Mar 31, 2019

Study Design

Enrollment

100 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group I (PET negative)
  Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Group II (PET positive)
  Patients receive R-ICE comprising rituximab IV on day 1, ifosfamide IV continuously over 24 hours and carboplatin IV over 30 minutes on day 2, and etoposide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously once daily starting on day 4 and continuing until blood counts recover. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

2-year Progression-Free Survival (PFS) [ Time Frame: Assessed every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry. ]

Locations (104)

Find similar trials in Palo Alto, CA

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