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

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ClinicalTrials.gov Identifier: NCT01701232
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Biocad

Tracking Information
First Submitted Date  ICMJE October 3, 2012
First Posted Date  ICMJE October 5, 2012
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE September 2011
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2017)
  • Overall response rate [ Time Frame: day 50 (cycle 4) ]
    Estimation of the overall response rate in each treatment arm at the end of treatment
  • CD20-positive cells count [ Time Frame: day 50 ]
    Comparison of peripheral blood B-cell depletion and repletion after BCD-020 and MabThera intravenous administration
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2012)
  • CD20-positive cells count [ Time Frame: day 50 ]
    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) ]
    Estimation of the overall response rate in each treatment arm at the end of treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2017)
  • Cmax [ Time Frame: day 22 ]
    Estimation of maximum rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera
  • AUC(0-168) [ Time Frame: 168 hours ]
    Estimation of rituximab exposition after administration of BCD-020 to that obtained after administration of MabThera
  • Complete response rate [ Time Frame: day 50 ]
    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 ]
    Evaluation of the safety profiles of BCD-020 and MabThera
  • Levels of binding and neutralizing antibodies to rituximab [ Time Frame: day 50 ]
    Immunogenicity assessment of BCD-020 and MabThera
  • AUC(0-1176), AUC(0-inf) [ Time Frame: day 50 ]
    Estimation of rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera
Original Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2012)
  • Cmax [ Time Frame: day 22 ]
    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 ]
    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 ]
    Evaluation of the safety profiles of BCD-020 and MabThera
  • Levels of binding and neutralizing antibodies to rituximab [ Time Frame: day 50 ]
    Immunogenicity assessment of BCD-020 and MabThera
  • AUC(0-1176), AUC(0-inf) [ Time Frame: day 50 ]
    Estimation of rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of BCD-020 in Therapy of Indolent Non-Hodgkin's Lymphoma
Official Title  ICMJE 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
Brief Summary

This international multi-center, randomized, controlled, open-label study investigated the pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (INN: 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 were randomized to receive 375 mg/m² BCD-020 as intravenous infusion once a week for 4 weeks or MabThera® at the same regimen.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Follicular Non-Hodgkin's Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Splenic Marginal Zone Lymphoma
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: MabThera
    Reference rituximab at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)
    Intervention: Biological: rituximab
  • Experimental: BCD-020
    Proposed rituximab biosimilar at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)
    Intervention: Biological: rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2017)
174
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2012)
92
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia,   India,   Russian Federation,   South Africa,   Ukraine
Removed Location Countries Belarus,   Brazil
 
Administrative Information
NCT Number  ICMJE NCT01701232
Other Study ID Numbers  ICMJE BIORIX (BCD-020-3)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Biocad
Study Sponsor  ICMJE Biocad
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Roman Ivanov, PhD,MD CJSC Biocad
PRS Account Biocad
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP