Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Completed · Phase 2

Conditions studied: Diffuse Large B-Cell Lymphoma, Lymphoma, Diffuse Large-Cell, Diffuse Large-Cell Lymphoma, Lymphoma

In brief

The purpose of this research study is to learn about the safety of the treatment with a combination of bendamustine and rituximab and to find out what effects, both good and bad this treatment has on DLBCL. In addition to learning about the combination of bendamustine and rituximab, the researchers are interested in learning about how this cancer treatment affects daily activities. Subjects will be asked to complete a Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional status, mental health, and level of social support. GAs are also designed to help the health care team understand how well subjects can carry out their day to day activities and to briefly describe what other medical conditions subjects may have. This assessment will help the health care team understand a subject's "functional age" (the age a subject functions at) as compared to a subject's actual age. The researchers also want to learn how chemotherapy affects the aging process in our bodies. This is done by measuring the amount of p16 in blood. Researchers want to understand if chemotherapy changes the levels of p16 in blood.

Key facts

Study ID

NCT01234467

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

23

Starts

2011-03-01

Expected to finish

2016-08-01

Last updated by the study team

2017-05-24

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with previously untreated , histologically confirmed, diffuse large B-cell lymphoma (DLBCL), immunophenotyped for CD20
• Age greater than or equal to 65 years
• Stage II-IV
• Measurable disease including lesions that can be accurately measured in 2 dimensions by CT and have a greatest transverse diameter of 1cm or greater, and/or by bone marrow histopathology.
• ECOG performance status of 0-3
• Deemed poor candidate for CHOP-R due to ejection fraction less than or equal to 45%, ECOG performance status of 2, or in the opinion of the treating physician, patient would not tolerate administration of CHOP-R chemotherapy for other reasons,
• Life expectancy of at least 3 months;
• Documented negative serologic testing for HIV, Hepatitis B (unless positive due to prior vaccination), and hepatitis C within the year prior to enrollment
• Adequate bone marrow function (without transfusion support within one week of screening) function:
• Hemoglobin > 8 g/dL
• Absolute neutrophil count (ANC) >1000 cells/mm3
• Platelet count > 75,000/mm3
• Adequate hepatic and renal function as demonstrated by:
• Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN)
• Total serum bilirubin < 2.5 x ULN
• Serum creatinine < 1.5 x ULN
• If sexually active male of reproductive capability, has agreed to use a medically accepted form of contraception from time of enrollment to completion of all follow-up study visits
• Signed an institutional review board (IRB) approved informed consent document

You may not qualify if…

• Central nervous system involvement by lymphoma
• History of previous allergic reactions to compounds of similar biological or chemical composition as rituximab or bendamustine
• Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective.
• Other active malignancies (except: non-melanoma skin cancer, cervical carcinoma in situ without evidence of disease, prostatic intraepithelial neoplasia without evidence of prostate cancer)
• Patients on strong inhibitors of CYP1A2.

Where it is running

• Seby B. Jones Cancer Center — Boone, North Carolina, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Northeast Medical Center — Concord, North Carolina, United States
• Moses Cone Regional Cancer Center — Greensboro, North Carolina, United States
• Leo Jenkins Cancer Center, East Carolina University Medical Center — Greenville, North Carolina, United States
• Rex Healthcare — Raleigh, North Carolina, United States
• Marion L. Shepard Cancer Center — Washington, North Carolina, United States

Full record on ClinicalTrials.gov

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