Last updated on February 2018

Bendamustine in Combination With Rituximab as a First-line Therapy Followed by Maintenance Therapy With Rituximab in Patients With Follicular Lymphoma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: follicular lymphoma
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Patients with the diagnosis of follicular lymphoma confirmed by immunohistochemistry (IHC) analysis in the reference laboratory
  • Written informed consent for the use of personal data approved by Independent Ethic Committee
  • Men and women patients, 18-75 years old
  • ECOG performance status 3
  • No previous treatment with chemotherapy and/or radiation therapy of follicular lymphoma

Exclusion Criteria:

  • The patient is participating in any clinical trials and/or receiving the experimental treatment.
  • Transformation of follicular lymphoma to large cell lymphoma (for example, follicular lymphoma IIIB graduation, diffuse large B-cell lymphoma).
  • Central nervous system involvement.
  • The presence of a second malignancy within the last 5 years prior to the inclusion into the study except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or prostate cancer.
  • Clinically significant cardiovascular or cerebro-vascular disease in the past 6 months, such as acute myocardial infarction, unstable angina, significant ventricular arrhythmia, severe heart failure (NYNA class IV), stroke, or uncontrolled hypertension.
  • Renal impairment (serum creatinine > 150 umol/L), except lymphoid infiltration of kidneys and tumor lysis syndrome.
  • Liver failure (except leukemic/lymphoid organ infiltration), acute hepatitis (serum bilirubin > 2 x ULN, the activity of ALT and AST > 4 x ULN, prothrombin index < than 50%).
  • Uncontrolled diabetes mellitus (serum glucose > 15 mmol/L)
  • Sepsis (septicopyemic focuses, hemodynamic instability, inefficiency of antibacterial therapy) or acute infectious diseases.
  • HIV, hepatitis B and C (including the absence of the Hbc and Hbs antibodies).
  • Life-threatening bleeding, except of bleeding from the gastrointestinal tract caused by neoplastic process.
  • Severe mental disorders (schizophrenia, major depressive syndrome and other productive symptoms).
  • Physical failure requiring constant care, cachexia (total protein < 35 g/L).
  • Known hypersensitivity to rituximab components.
  • Known hypersensitivity to bendamustine components.
  • Pregnant or currently breast-feeding woman
  • Neutrophils count < 1500/mm3 and/or platelets count < 75000/mm3.
  • Surgery prior 15 days before therapy initiation.
  • In case of serious infectious complications relief, uncontrolled diabetes, hemorrhagic syndrome, hypertension patient may be included into the study

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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