A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma
Filgrastim
+ Pegfilgrastim
+ Rituximab
Hemic and Lymphatic Diseases+8
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: September 1, 2005
Actual date on which the first participant was enrolled.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, pegylated doxorubicin hydrochloride liposome (HCl), vincristine, and prednisone. * Determine the cardiotoxicity and myelosuppression of this regimen in these patients. Secondary * Determine disease-free survival and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive rituximab intravenous (IV), cyclophosphamide IV over 1-1½ hours, pegylated doxorubicin HCl liposome IV over 1 hour, and vincristine IV on day 1, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 (24 hours after the completion of chemotherapy). Treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity, disease progression, active hepatitis B virus infection, or hepatitis. Patients with no response OR who achieve less than a partial response after 4 courses are removed from the study. Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study within 27 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 61 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, United StatesOpen Hembree Mercy Cancer Center at St. Edward Mercy Medical Center in Google MapsCCOP - Grand Rapids
Grand Rapids, United StatesCCOP - Kalamazoo
Kalamazoo, United StatesCancer Research for the Ozarks
Springfield, United States