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A Multicenter Open-label Randomized Study of BCD-020 (Rituximab, CJSC BIOCAD, Russia) Efficacy and Safety in Comparison With MabThera (F. Hoffmann-La Roche Ltd., Switzerland) in Monotherapy of CD20-positive Indolent Non-Hodgkin's Lymphoma


Phase 2/Phase 3
18 Years
95 Years
Open (Enrolling)
Both
Follicular Non-Hodgkin's Lymphoma, Nodal Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma

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Trial Information

A Multicenter Open-label Randomized Study of BCD-020 (Rituximab, CJSC BIOCAD, Russia) Efficacy and Safety in Comparison With MabThera (F. Hoffmann-La Roche Ltd., Switzerland) in Monotherapy of CD20-positive Indolent Non-Hodgkin's Lymphoma


Inclusion Criteria:



- 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
procedures;

- Willingness of patients with preserved reproductive function to use reliable
contraception methods (at least two contraception methods in women, e.g., spermicide
and condom).

Exclusion Criteria:

- 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 µµmol/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
suicidal 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
protocol;

- 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
infusion;

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CD20-positive cells count

Outcome Description:

Comparison of peripheral blood B-cell depletion and repletion after BCD-020 and MabThera intravenous administration

Outcome Time Frame:

day 50

Safety Issue:

No

Principal Investigator

Roman Ivanov, PhD,MD

Investigator Role:

Study Director

Investigator Affiliation:

CJSC Biocad

Authority:

Russia: Ministry of Health of the Russian Federation

Study ID:

BIORIX

NCT ID:

NCT01701232

Start Date:

September 2011

Completion Date:

December 2013

Related Keywords:

  • Follicular Non-Hodgkin's Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Splenic Marginal Zone Lymphoma
  • lymphoma, non-Hodgkin's
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell, Marginal Zone

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