Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Condition: Diffuse Large B-Cell Lymphoma; Lymphoma, Diffuse Large-Cell; Diffuse Large-Cell Lymphoma; Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin
Intervention: Bendamustine; Rituximab
Intervention description: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles; Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Diffuse Large B-Cell Lymphoma; Elderly; Newly Diagnosed; Lineberger Comprehensive Cancer Center; University of North Carolina; Bendamustine; Rituximab; Rituxan; Treanda; Phase 2; Geriatric; Lymphoma

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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.