Phase 2
N=56
S0213 Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00041132 ↗Enrolled (actual)
56
Serious AEs
8.2%
Results posted
Nov 2012
Primary outcome: Primary: Progression-free Survival — 90 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- filgrastim (Biological); rituximab (Biological); cyclophosphamide (Drug); cytarabine (Drug); dexamethasone (Drug); doxorubicin (Drug); leucovorin (Drug); methotrexate (Drug); vincristine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
90 | — |
| SECONDARY Response |
42 | — |
| SECONDARY Overall Survival |
92 | — |
Summary
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. Combining rituximab with chemotherapy may kill more cancer cells.
PURPOSE: Phase II pilot study to study the effectiveness of combining chemotherapy with rituximab in treating patients who have newly diagnosed mantle cell lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically proven stage III/IV or bulky stage II mantle cell lymphoma of one of the following histologic subtypes:
- Nodular
- Diffuse
- Mantle zone
- Blastic
- Newly diagnosed and previously untreated disease
- Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
- 18 to 69
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100, 000/mm^3 (50,000/mm^3 if marrow involvement present)
Hepatic:
- Bilirubin no greater than 1.5 mg/dL (5.0 mg/dL if hepatic involvement present)
Renal:
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance greater than 50 mL/min
Cardiovascular:
- Ejection fraction at least 50% by MUGA or 2-D echocardiogram
- No significant abnormalities by EKG
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Willing to receive blood product transfusions
- No known sensitivity to E. coli-derived proteins
- No known AIDS syndrome or HIV-associated complex
- 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 antibody therapy
Chemotherapy:
- No prior chemotherapy for lymphoma
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for lymphoma
Surgery:
- Not specified
Data sourced from ClinicalTrials.gov (NCT00041132). 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.