Last updated on September 2016

Safety and Efficacy Study of BCD-020 in Therapy of Non-Hodgkin's Lymphoma

Are you eligible to participate in this study?

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

  • Conditions: Follicular Non-Hodgkin's Lymphoma | Nodal Marginal Zone Lymphoma | Splenic Marginal Zone Lymphoma
  • Age: Between 18 - 95 Years
  • Gender: Male or Female
  • Other:
    Having signed a written informed consent;
    Patients' age is 18 years or more;
    Diagnosis of CD20-positive indolent non-Hodgkin lymphoma of following morphological
    types:Follicular non-Hodgkin lymphoma stage II-IV according to Ann Arbor, grade
    I-II;Nodal marginal zone lymphoma stage II-IV according to Ann Arbor; Splenic
    marginal zone lymphoma.
    Life expectancy of not less than 3 months after the enrollment in the study;
    Morphological and immunohistochemical examination of the tumor (both lymph node
    biopsy and bone marrow biopsy) - within 3 months before the enrollment in the study ;
    Performance status ≤2 on the ECOG scale;
    Hemoglobin > 80 g/l; leukocyte count ≥ 3.0×109/l but less than 25×109/l, absolute
    neutrophil count ≥1.5×109/l, platelet count ≥100×109/l;
    Presence of at least one measurable lesion;
    Patient's ability in the investigator's opinion to comply with the protocol
    Willingness of patients with preserved reproductive function to use reliable
    contraception methods (at least two contraception methods in women, e.g., spermicide
    and condom).

You may not be eligible for this study if the following are true:

  • Bulky disease - size of any single lesion more than 10 cm in the greatest diameter;
    Secondary transformation to high-grade lymphoma;
    Other types of non-Hodgkin lymphomas apart from follicular non-Hodgkin stage II-IV
    lymphoma according to Ann Arbor, grade 1,2; nodal marginal zone lymphoma stage II-IV
    according to Ann Arbor; splenic marginal zone lymphoma.
    Patients regularly taking corticosteroids during 1 month preceding the enrollment in
    the study;
    Occurrence of other (aside from NHL) diseases that can distort the assessment of the
    main disease symptoms expression; mask, enhance, modify the main disease symptoms or
    induce clinical and laboratory-instrumental symptoms similar to the non-Hodgkin
    lymphomas; Severe resistant hypertension; Decompensated forms of heart (NYHA class
    ХСН III, IV), liver and kidney disorders (creatinine level >133 µmol/l, AST, ALT, and
    bilirubin level 3 times exceeding the norm) except for the cases where the symptom is
    caused by lymphoma; Decompensated respiratory failure; Tumor infiltration of the
    lungs; Decompensated diabetes mellitus; Active autoimmune diseases; Ongoing
    infections requiring antimicrobial therapy.
    Usage of the drugs:
    At any time prior to the enrollment into the study - interferon-based drugs or monoclonal
    antibodies for the treatment of NHL; Chemotherapy or radiotherapy was completed less than
    21 day prior to the enrollment into the study; Vaccination within 1 week prior to the
    enrollment into the study;
    Presence of any psychiatric disorders including major depressive conditions and/or
    uicidal thoughts in anamnesis that in opinion of the investigator may put a patient
    at an excessive risk or influence the ability of patients to fulfill the study
    Myocardial infarction less than 1 month before the enrollment into the study;
    Severe CNS or PNS dysfunctions;
    Drug and alcohol addiction;
    Known HIV, HBV, HCV infection, syphilis;
    Known primary or secondary immunodeficiency;
    Primary CNS lymphoma or metastasis in the CNS;
    Known intolerance or allergy to mouse proteins or any components of the study drugs,
    and also to the premedication drugs;
    Pregnancy or lactation;
    Prior or concomitant malignances except for adequately treated basal cell carcinoma
    and in situ cervical cancer;
    Any restraints or impossibility to administer the study drug via an intravenous
    Major surgery within 1 week prior to the enrollment into the study;
    Simultaneous participation in any other clinical study or any preceding participation
    in other studies within 3 months prior to enrollment in this study.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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