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Follicular Non-Hodgkin's LymphomaPhase 3NCT01701232

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

A Phase 3 study testing rituximab in people with Follicular Non-Hodgkin's Lymphoma and Nodal Marginal Zone Lymphoma, run by Biocad at 62 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 95 years
What is being tested?
rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
62 sitesin 5 countries
Study dates
Sep 2011to Jan 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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).

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

62 sites in 5 countries.

62 sites in 5 countries

Russia36 sites

  • Arkhangelsk District Clinical Oncology Dispensary

    Arkhangelsk, 163045

  • City Hospital N8

    Barnaul, 656010

  • Public health facility "Irkutsk Regional Oncology Center"

    Irkutsk, 664035

  • Ivanovo Regional Oncology Center

    Ivanovo, 153013

  • State Health Care Institution "Republican Clinical Cancer Center," the Ministry of Health of the Udmurt Republic

    Izhevsk, 426009

  • Public health facility "Kemerovo Regional Hospital"

    Kemerovo, 650066

  • Clinical Oncology Dispensary N1

    Krasnodar, 350040

  • Public health facility "Kursk Regional Cancer Center," Health Committee of Kursk region

    Kursk, 305035

  • Public health facility "Lipetsk Regional Oncology Center"

    Lipetsk, 398005

  • N.N. Burdenko General Military Clinical Hospital

    Moscow, 105229

  • Russian Medical Academy of Post-Graduate Education, Ministry of Health and Social Development of the Russian Federation

    Moscow, 123995

  • Research Center for Hematology MHSD RF

    Moscow, 125167

  • Official body of the health of the city of Moscow "Moscow City Clinical Hospital named after S. P. Botkin"

    Moscow, 125284

  • Medical Radiological Research Center, Ministry of Health and Social Development of the Russian Federation

    Obninsk, 249036

  • Regional government health care "Oryol Regional Hospital"

    Oryol, 302028

  • Perm Region Oncology Dispensary

    Perm, 614066

  • V.A. Baranov Republican Hospital of Ministry of Health republic Karelia

    Petrozavodsk, 185000

  • Pyatigorsk Oncology Center

    Pyatigorsk, 357502

  • Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency

    Saint Petersburg, 191024

  • St. Petersburg State Health Care Institution "Alexander City Hospital"

    Saint Petersburg, 193312

  • Saint Petersburg City Clinical Oncology Center

    Saint Petersburg, 197022

  • Saint Petersburg Pavlov State Medical University

    Saint Petersburg, 197022

  • V.A. Almazov Federal Center for Heart, Blood and Endocrinology, Ministry of Health and Social Development of the Russian Federation

    Saint Petersburg, 197341

  • N.N.Petrov Oncology Research Center

    Saint Petersburg, 197758

  • Russian scientific center of radiology and surgery technologies

    Saint Petersburg

  • The federal government military educational institution of higher education, "Military Medical Academy named after SM Kirov's' Ministry of Defense"

    Saint Petersurg, 194044

  • Provincial health official body "Smolensk Regional Clinical Oncological Dispensary"

    Smolensk, 214000

  • Oncology Dispensary 2

    Sochi, 354057

  • Tambov Regional Oncology Center

    Tambov, 390013

  • Municipal Health "Clinical Hospital № 5" Togliatti

    Tolyatti, 445846

  • Tula Regional Hospital

    Tula, 300053

  • Public health care setting of the Tyumen region "Regional Oncology Center"

    Tyumen, 625041

  • State Health Care Institution Republican Clinical Hospital named after G. G. Kuvatova

    Ufa, 450005

  • Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan

    Ufa, 450054

  • Volgograd District Oncology Dispensary №1

    Volgograd, 400138

  • Municipal Institution "Central City Hospital № 7"

    Yekaterinburg, 620137

Other trials in Russia

India19 sites

  • HCG Multi Specialty Hospitals

    Ahmedabad, 380006

  • Department of Medical Oncology, Navneet Memorial Hospital, "Sushrusha"

    Ahmedabad, 380009

  • Sujan Surgicals

    Amaravati

  • HCG Bangalore Institute of Oncology

    Bangalore, 560027

  • Department of Medicine (Haemotology), St.John's Medical College Hospital

    Bangalore, 560034

  • Narayana Hrudayalaya Hospitals

    Bangalore, 560099

  • Srinivasam Cancer Care Hospital

    Bangalore

  • All India Institute of medical Sciences (AIIMS)

    Bhubaneswar

  • Acharya Tulasi Regional Cancer Treatment and Research Centre

    Bikaner

  • G.Kuppuswamy Naidu Memorial Hospital

    Coimbatore, 641037

  • Medical Oncology Department, The Karnatak Cancer Therapy and Research Institute

    Hubli, 580025

  • BIBI General hospital & cancer center

    Hyderabad, 500024

  • Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital and Research Institute

    Hyderabad, 500034

  • Omega Hospitals

    Hyderabad, 500034

  • Nilratan Siracar Medical College & Hospital

    Kolkata

  • King George Medical University

    Lucknow

  • Department of Radiation Oncology, Meenakshi Mission Hospital & Research Centre

    Madurai, 625107

  • Manas Super Speciality Hospital

    Nashik

  • City Cancer Center

    Vijayawada

Other trials in India

Colombia3 sites

  • Instituto Nacional de Cancerología

    Bogotá

  • Fundación Reina Isabel

    Cali

  • Hospital Pablo Tobon Uribe

    Medellín

Other trials in Colombia

Ukraine3 sites

  • Khmel'nyts'kyy Regional Hospital, Hematology Department

    Khmelnytskyi, 29000

  • National Cancer Institute of Ukraine, Oncohematology Department

    Kiev, 03022

  • State Institution "Institute of Blood Pathology and Transfusion Medicine AMS of Ukraine", Hematology Department

    Lviv, 79044

Other trials in Ukraine

South Africa1 site

  • Medi-Clinic Vereeniging

    Vereeniging

Other trials in South Africa

About this study

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

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.

Being tested
rituximab
Keywords
lymphoma, non-Hodgkin's
Medical subject headings
Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rituximabBiological

    Also called Biological: BCD-020, MabThera

    Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22)

Study groups in NCT01701232
Study groupRoleWhat they receive
MabTheraActive comparatorReference rituximab at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)
Receives: Biological: rituximab
BCD-020ExperimentalProposed rituximab biosimilar at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)
Receives: Biological: rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    Estimation of the overall response rate in each treatment arm at the end of treatment

    Measured: day 50 (cycle 4)

  2. CD20-positive cells count

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

    Measured: day 50

Secondary outcomes (6)

  1. Cmax

    Estimation of maximum rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera

    Measured: day 22

  2. AUC(0-168)

    Estimation of rituximab exposition after administration of BCD-020 to that obtained after administration of MabThera

    Measured: 168 hours

  3. Complete response rate

    Assessment of complete response rates of BCD-020 and MabThera given as a monotherapy at the end/completion of the treatment

    Measured: day 50

  4. Frequency of AEs/sAEs grade 3-4 (CTCAE v.4.03)

    Evaluation of the safety profiles of BCD-020 and MabThera

    Measured: day 50

  5. Levels of binding and neutralizing antibodies to rituximab

    Immunogenicity assessment of BCD-020 and MabThera

    Measured: day 50

  6. AUC(0-1176), AUC(0-inf)

    Estimation of rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera

    Measured: day 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2012 (estimated)
  2. Study startSep 2011
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01701232
Sponsor's protocol ID
BIORIX (BCD-020-3)
Status last verified
Nov 2017
First submitted
3 Oct 2012
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rituximab in people with Follicular Non-Hodgkin's Lymphoma and Nodal Marginal Zone Lymphoma, run by Biocad at 62 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in Russia, India, Colombia, Ukraine, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: day 50 (cycle 4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01701232.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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