Phase 2
Completed N=98
Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma
Source: ClinicalTrials.gov NCT00039195 ↗Enrolled (actual)
98
Serious AEs
20.4%
Results posted
Aug 2016
Primary outcomePrimary: Progression Free Survival — 79 percentage of patients progression free
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 chemotherapy with monoclonal antibody therapy, total-body irradiation, and peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy with rituximab followed by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral stem cell transplant works in treating patients with lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
79 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive diffuse large B-cell lymphoma
- CD20-positive disease
- Age-adjusted International Prognostic Index II or III defined by the presence of at least 1 of the following:
- Karnofsky performance status 10-70%
- Lactate dehydrogenase greater than 200 U/L
- Stage III or IV disease
- Positron emission tomography avid measurable disease
- No CNS involvement
PATIENT CHARACTERISTICS:
Age:
- 18 to 64
Performance status:
- See Disease Characteristics
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 50,000/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease or pattern consistent with Gilbert's disease
- Hepatitis B surface antigen and hepatitis C antibody negative
- No chronic, active, or persistent hepatitis
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
- No chronic renal insufficiency
Cardiovascular:
- Ejection fraction at least 50% by echocardiogram or MUGA scan
- No myocardial infarction within the past 6 months
- No unstable angina
- No cardiac arrhythmias except chronic atrial fibrillation
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- HIV negative
- No other medical illness that would preclude study
- No uncontrolled infection
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy for malignancy
Chemotherapy:
- No prior chemotherapy for malignancy
Endocrine therapy:
- Prior steroids allowed if received no more than 1 week of therapy
Radiotherapy:
- No prior radiotherapy for malignancy
Surgery:
- No prior surgery for malignancy
Other:
- No other prior therapy for malignancy
Data sourced from ClinicalTrials.gov (NCT00039195). 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. Informational only — not medical advice.