Phase 2
N=87
S0801 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00770224 ↗Enrolled (actual)
87
Serious AEs
0.7%
Results posted
Nov 2018
Primary outcome: Primary: Percentage of Participants With 3-year Progression-free Survival (PFS) — 90 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Biological); tositumomab (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
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With 3-year Progression-free Survival (PFS) |
90 | — |
| SECONDARY 5-year Progression-free Survival |
85 | — |
| SECONDARY 5-year Overall Survival |
94 | — |
| SECONDARY Response Rate |
61; 22; 1 | — |
| SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
1; 0; 2; 0; 1; 0 | — |
Summary
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. 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, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving a radiolabeled monoclonal antibody together with rituximab and combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving iodine I 131 tositumomab together with rituximab and combination chemotherapy and to see how well it works in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed* grade 1, 2, or 3 follicular B-cell non-Hodgkin lymphoma meeting the following criteria:
- Bulky stage II or stage III or IV disease
- Diffuse large cell component must be 42 days but < 6 months allowed
- Previously untreated disease
- Bidimensionally measurable disease
- No clinical evidence of central nervous system (CNS) involvement by lymphoma
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Cardiac ejection fraction ≥ 45% by multigated acquisition scan (MUGA) or ECHO
- No significant cardiac abnormalities
- No known HIV positivity
- No requirement for continuous supplemental oxygen therapy
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently in complete remission
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 12 months after completion of maintenance therapy
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
- No prior solid organ transplantation
Data sourced from ClinicalTrials.gov (NCT00770224). 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.