Phase 3
N=571
S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00006721 ↗Enrolled (actual)
571
Serious AEs
3.5%
Results posted
Feb 2013
Primary outcome: Primary: Progression-free Survival at 2 Years — 76; 80 percentage of participants — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rituximab (Biological); cyclophosphamide (Drug); doxorubicin (Drug); prednisone (Drug); vincristine (Drug); tositumomab (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival at 2 Years |
76; 80 | 0.11 |
| PRIMARY Progression-free Survival at 5 Years |
60; 66 | — |
| PRIMARY Overall Survival at 2 Years |
97; 93 | 0.08 |
| PRIMARY Overall Survival at 5 Years |
92; 86 | — |
| SECONDARY Objective Response (Confirmed and Unconfirmed Complete and Partial Responses) |
224; 223 | — |
| SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
0; 0; 1; 0; 4; 3 | — |
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma
- Grade I-III disease
- Cluster of differentiation antigen 20 (CD20) antigen positive
- Fewer than 5, 000/mm^3 circulating lymphoid cells on a white blood cell (WBC) differential count
- Bidimensionally measurable disease
- Bone marrow aspiration and biopsy within the past 42 days
- No clinical evidence of central nervous system (CNS) involvement by lymphoma
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
- Granulocyte count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No impaired cardiac status, including:
- Severe coronary artery disease
- Cardiomyopathy
- Congestive heart failure
- Serious arrhythmia
- Ejection fraction at least lower limit of normal by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram for questionable cardiac history
Other:
- No hypersensitivity to iodine
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after study participation
- HIV negative
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior monoclonal antibodies for cancer
Chemotherapy:
- No prior chemotherapy for lymphoma
- Prior prednisone for non-lymphoma related illnesses allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for lymphoma
Surgery:
- See Disease Characteristics
Data sourced from ClinicalTrials.gov (NCT00006721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.