Combination Chemotherapy With or Without Rituximab in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - 120 |
| Updated: | 1/19/2018 |
| Start Date: | September 1999 |
| End Date: | March 2003 |
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
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 cancer
cells and either kill them or deliver cancer-killing substances to them without harming
normal cells. It is not yet known whether combination chemotherapy plus rituximab is more
effective than combination chemotherapy alone for non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
with or without rituximab in treating patients who have newly diagnosed non-Hodgkin's
lymphoma that has not been treated previously.
so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer
cells and either kill them or deliver cancer-killing substances to them without harming
normal cells. It is not yet known whether combination chemotherapy plus rituximab is more
effective than combination chemotherapy alone for non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
with or without rituximab in treating patients who have newly diagnosed non-Hodgkin's
lymphoma that has not been treated previously.
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.
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.
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
We found this trial at
2
sites
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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