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

This study is currently recruiting participants.
Verified February 2014 by Biocad
Sponsor:
Collaborator:
SMO Clinical Research (I) Pvt Ltd
Information provided by (Responsible Party):
Biocad
ClinicalTrials.gov Identifier:
NCT01701232
First received: October 3, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

This international multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (NN: rituximab, CJSC Biocad) versus MabThera (INN: rituximab, F. Hoffmann La Roche, Ltd.) both administered as a monotherapy of patients with indolent non-Hodgkin's lymphoma.

Patients will be randomized to receive 375 mg/m² BCD-020 as intravenous infusion once a week for 4 weeks or MabThera at the same regimen.


Condition Intervention Phase
Follicular Non-Hodgkin's Lymphoma
Nodal Marginal Zone Lymphoma
Splenic Marginal Zone Lymphoma
Biological: rituximab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biocad:

Primary Outcome Measures:
  • CD20-positive cells count [ Time Frame: day 50 ] [ Designated as safety issue: No ]
    Comparison of peripheral blood B-cell depletion and repletion after BCD-020 and MabThera intravenous administration

  • Overall response rate [ Time Frame: day 50 (cycle 4) ] [ Designated as safety issue: No ]
    Estimation of the overall response rate in each treatment arm at the end of treatment


Secondary Outcome Measures:
  • Cmax [ Time Frame: day 22 ] [ Designated as safety issue: No ]
    Estimation of of rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera

  • Complete response rate [ Time Frame: day 50 ] [ Designated as safety issue: No ]
    Assessment of complete response rates of BCD-020 and MabThera given as a monotherapy at the end/completion of the treatment

  • Frequency of AEs/sAEs grade 3-4 (CTCAE v.4.03) [ Time Frame: day 50 ] [ Designated as safety issue: Yes ]
    Evaluation of the safety profiles of BCD-020 and MabThera

  • Levels of binding and neutralizing antibodies to rituximab [ Time Frame: day 50 ] [ Designated as safety issue: Yes ]
    Immunogenicity assessment of BCD-020 and MabThera

  • AUC(0-1176), AUC(0-inf) [ Time Frame: day 50 ] [ Designated as safety issue: No ]
    Estimation of rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera


Estimated Enrollment: 134
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MabThera
Patients will receive MabThera at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1-8-15 and 22)
Biological: rituximab
Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22)
Other Name: Biological: BCD-020, MabThera
Experimental: BCD-020
Patients will receive BCD-020 at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1-8-15 and 22)
Biological: rituximab
Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22)
Other Name: Biological: BCD-020, MabThera

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701232

Contacts
Contact: Andrey Biryulin, MD (812) 3804933 ext 925 Biryulin@biocad.ru
Contact: Ekaterina Chernyaeva, MD (495) 9926628 ext 193 Chernyaeva@biocad.ru

  Show 73 Study Locations
Sponsors and Collaborators
Biocad
SMO Clinical Research (I) Pvt Ltd
Investigators
Study Director: Roman Ivanov, PhD,MD CJSC Biocad
  More Information

Additional Information:
No publications provided

Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT01701232     History of Changes
Other Study ID Numbers: BIORIX (BCD-020-3)
Study First Received: October 3, 2012
Last Updated: February 4, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation
India: Drugs Controller General of India
Ukraine: Ministry of Health

Keywords provided by Biocad:
lymphoma, non-Hodgkin's

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 22, 2014