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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Lymphoma
Title   Phase II Study of Bendamustine and Ofatumumab in Elderly Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma Who are Poor Candidates for R-CHOP Chemotherapy
Description   To evaluate the effectiveness and side effects of ofatumumab and bendamustine when given in combination to subjects with diffuse large B-cell lymphoma.
IRB Number   Pro4239
Inclusion/Notes   INCLUSION:
  • Histologically confirmed CD20-positive DLBCL.

  • Newly diagnosed, stage III-IV DLBCL and considered poor candidates for R-CHOP.

  • Age greater than or equal to 70 years.

  • At least one of the following criteria:
    - ECOG PS 2.
    - Cardiac compromise precluding anthracycline therapy.
    - Previous anthracycline therapy for other malignancy precluding further anthracycline therapy.
    - Severe coexisting medical problems.
    - General frailty.

  • ECOG performance status scale 0-2
  • Measurable disease with at least one bidimensional lymph node or tumor mass >1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by CT.

  • Patient must be HBV sAg and HBV cAb negative within 6 weeks of screening.

  • Patient must understand and voluntarily sign the IRB-approved informed consent.

  • Life expectancy 3 months.

  • Laboratory parameters:
    - Absolute neutrophil count 1,000 cells/mm3.
    - Platelet count 75,000 cells/mm3.
    - Hemoglobin 8 g/dL.
    - Creatinine 2.0 mg/dL or creatinine clearance 40 mL/min (calculated or 24-hour urine sample).
    - AST/SGOT 2.0 x ULN ( 5.0 x ULN if secondary to lymphoma).
    - ALT/SGPT 2.0 x ULN ( 5.0 x ULN if secondary to lymphoma).
    - Bilirubin level of <2.0 mg/dL, unless secondary to Gilbert's disease (or pattern consistent with Gilbert's).

  • Patients with active/symptomatic central nervous system (CNS) involvement based on clinical evaluation by lumbar puncture, PET, CT or MRI.

  • Known sensitivity to bendamustine or any component of bendamustine.

  • Known anaphylaxis or sensitivity to ofatumumab.

  • Major surgery within 28 days of Cycle 1, Day 1. Patients undergoing minor surgery within 7 days of Cycle 1, Day 1 (no wait needed for port placement).

  • Prior chemotherapy, immunotherapy, or irradiation for lymphoma.

  • Prior use of investigational anti-cancer agents for lymphoma.

  • HIV-related lymphoma.

  • Known active HIV or HCV infection, or known seropositivity for HIV, or current or chronic HBV or HCV infection. HBV test required at screening or a negative result within 6 weeks of screening.

  • Concurrent active or history of other malignancies, except non-melanoma skin cancer or carcinoma in situ of cervix or breast. Patients with previous malignancies are eligible.

  • provided they have been treated with curative intent and disease free for 1 year.
  • Serious (grade 3-4), active, intercurrent infection requiring therapy, or deep seated or systemic mycotic infections.

  • Myocardial infarction within 6 months prior to registration or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute.

  • ischemia or significant conduction system abnormalities, in the judgment of the Investigator.
  • Concurrent uncontrolled serious medical or psychiatric conditions likely to interfere with participation in this clinical study, in the judgment of the Investigator.

  • Patients who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic
    liver disease per investigator assessment).

  • Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study.

  • Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient.

  • Male patients unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
Status   Recruiting
Location   Physician / Investigator Office
Principal Name    Ruben Augusto Saez MD
Contact Name   Lee Knox
Phone   (972) 739-3089

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