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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: May 23, 2014
Last verified: May 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 23, 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 July 28, 2014