Status:
COMPLETED
Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Ortho Biotech, Inc.
Conditions:
Lymphoma
Eligibility:
All Genders
61+ years
Phase:
PHASE2
Brief Summary
RATIONALE: 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 o...
Detailed Description
OBJECTIVES: Primary * Determine the clinical response rate in older patients with previously untreated aggressive diffuse large B-cell stage II-IV lymphoma treated with rituximab, cyclophosphamide, ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diffuse large B-cell lymphoma
- Stage II, III, or IV disease
- Previously untreated disease
- Measurable or evaluable disease
- No primary central nervous system (CNS) lymphoma or follicular B-cell lymphoma
- PATIENT CHARACTERISTICS:
- Age
- 61 and over
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count \> 1,000/mm\^3\*
- Platelet count \> 100,000/mm\^3\* NOTE: \* Unless due to lymphoma-related hypersplenism or bone marrow infiltration
- Hepatic
- Bilirubin \< 2 mg/dL
- Hepatitis B surface antigen negative
- Hepatitis B core antibody negative
- Hepatitis C Virus antibody negative
- Renal
- Creatinine \< 2 mg/dL
- Cardiovascular
- left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or ple gated acquisition (MUGA) scan
- No uncontrolled hypertension or cardiac symptoms
- Cardiologist consultation required for patients with stage A cardiac failure or any of the following known heart diseases:
- Diastolic dysfunction
- Prior coronary artery bypass graft
- Prior percutaneous transluminal coronary angioplasty
- Prior stent insertion
- Prior radiotherapy to the chest
- No myocardial infarction within the past 6 months
- No New York Heart Association class II-IV heart failure
- No uncontrolled angina
- No severe uncontrolled ventricular arrhythmias
- No clinically significant pericardial disease
- No acute ischemic or active conduction system abnormality by electrocardiogram (EKG)
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No psychiatric illness that would preclude study compliance or giving informed consent
- No other major life-threatening illness that would preclude study treatment
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- See Cardiovascular
- Surgery
- See Cardiovascular
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00101010
Start Date
September 1 2005
End Date
September 1 2014
Last Update
October 19 2020
Active Locations (7)
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1
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72913
2
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
3
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
4
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65804