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A Phase III Randomized Trial of CHOP Chemotherapy Plus Rituxan (IDEC-C2B8) Versus CHOP Chemotherapy Alone for Newly Diagnosed, Previously Untreated, Aggressive Non-Hodgkin's Lymphoma


Phase 3
19 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase III Randomized Trial of CHOP Chemotherapy Plus Rituxan (IDEC-C2B8) Versus CHOP Chemotherapy Alone for Newly Diagnosed, Previously Untreated, Aggressive Non-Hodgkin's Lymphoma


OBJECTIVES: I. Determine whether the addition of rituximab to cyclophosphamide, doxorubicin,
vincristine, and prednisone (CHOP) increases the failure-free survival of patients with
newly diagnosed, previously untreated, aggressive B-cell non-Hodgkin's lymphoma. II.
Determine whether the addition of rituximab changes the toxicity profile attributed to CHOP
chemotherapy in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center,
histology (diffuse small cleaved cell, diffuse mixed, and diffuse large cell vs
immunoblastic large cell, mantle cell, and marginal zone), and risk group (low vs
intermediate vs high). Patients enter one of two treatment arms: Arm I: Patients receive
rituximab IV on day 1, followed by cyclophosphamide IV, doxorubicin IV, vincristine IV, and
oral prednisone for 5 consecutive days beginning on day 3. Arm II: Patients receive
cyclophosphamide IV, doxorubicin IV, vincristine IV, and oral prednisone daily for 5
consecutive days beginning on day 1. Treatment repeats every 21 days for up to 6 courses in
the absence of disease progression or unacceptable toxicity. Patients will be followed for 3
years.

PROJECTED ACCRUAL: A total of 270 patients (135 per treatment arm) will be accrued for this
study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, aggressive (stage
II-IV) B-cell non-Hodgkin's lymphoma, including but not limited to: Mantle cell Diffuse
large cell Diffuse mixed cell Anaplastic large cell (B-cell type) Diffuse small cleaved
cell Marginal zone lymphoma No prior T-cell lymphoma CD20 positive

PATIENT CHARACTERISTICS: Age: 19 and over Performance status: WHO 0-2 Karnofsky 70-100%
Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count greater than
1,000/mm3 (unless due to non-Hodgkin's lymphoma (NHL) bone marrow involvement) Hepatic:
Unless due to NHL: Bilirubin less than 3.0 mg/dL Alkaline phosphatase less than 3 times
upper limit of normal (ULN) SGOT less than 3 times ULN Renal: Not specified Other: Not
pregnant or nursing Fertile patients must use effective contraception HIV negative No
other serious disease or medical condition that would interfere with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No other
concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids (unless for
prevention of nausea or vomiting) Nonsteroidal hormones for nonlymphoma related conditions
allowed (e.g., insulin for diabetes) Radiotherapy: No concurrent radiotherapy Surgery: Not
specified Other: No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Julie M. Vose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska

Authority:

United States: Federal Government

Study ID:

447-97

NCT ID:

NCT00004112

Start Date:

September 1999

Completion Date:

March 2003

Related Keywords:

  • Lymphoma
  • stage II adult diffuse small cleaved cell lymphoma
  • stage II adult diffuse mixed cell lymphoma
  • stage II adult diffuse large cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • anaplastic large cell lymphoma
  • stage II mantle cell lymphoma
  • stage II small lymphocytic lymphoma
  • stage II marginal zone lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
University of Nebraska Medical Center Omaha, Nebraska  68198-3330