A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects

October 21, 2013 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Phase Ib, Double Blind RCT to Evaluate and Compare the PK, PD and Safety of MabThera® With TL011, in Combination With CHOP, in Subjects With CD20+ DLBCL

This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse large B cell lymphoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • Teva Investigational Site 59005
      • Plovdiv, Bulgaria
        • Teva Investigational Site 59003
      • Sofia, Bulgaria
        • Teva Investigational Site 59001
      • Sofia, Bulgaria
        • Teva Investigational Site 59002
      • Varna, Bulgaria
        • Teva Investigational Site 59004
  • Estonia
      • Tallinn, Estonia
        • Teva Investigational Site 55001
      • Tartu, Estonia
        • Teva Investigational Site 55002
  • France
      • Paris Cedex 13, France
        • Teva Investigational Site 35066
  • Hungary
      • Debrecen, Hungary
        • Teva Investigational Site 51026
  • Italy
      • Firenze, Italy
        • Teva Investigational Site 30001
      • Napoli, Italy
        • Teva Investigational Site 30002
  • Latvia
      • Daugavpils, Latvia
        • Teva Investigational Site 56002
      • Riga, Latvia
        • Teva Investigational Site 56001
      • Riga, Latvia
        • Teva Investigational Site 56003
  • Poland
      • Warsaw, Poland
        • Teva Investigational Site 53010
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Teva Investigational Site 50011
      • Chelyabinsk, Russian Federation
        • Teva Investigational Site 50001
      • Ekaterinburg, Russian Federation
        • Teva Investigational Site 50004
      • Kazan, Russian Federation
        • Teva Investigational Site 50006
      • Kursk, Russian Federation
        • Teva Investigational Site 50014
      • Moscow, Russian Federation
        • Teva Investigational Site 50005
      • Moscow, Russian Federation
        • Teva Investigational Site 50009
      • Moscow, Russian Federation
        • Teva Investigational Site 50010
      • Novosibirsk, Russian Federation
        • Teva Investigational Site 50003
      • Pyatigorsk, Russian Federation
        • Teva Investigational Site 50017
      • St. Petersburg, Russian Federation
        • Teva Investigational Site 50012
      • Tomsk, Russian Federation
        • Teva Investigational Site 50015
  • Spain
      • Elche-Alicante, Spain
        • Teva Investigational Site 31005
      • Las Palmas de Gran Canaria, Spain
        • Teva Investigational Site 31006
      • Madrid, Spain
        • Teva Investigational Site 31002
      • Majadahonda-Madrid, Spain
        • Teva Investigational Site 31001
      • Valencia, Spain
        • Teva Investigational Site 31003
      • Valencia, Spain
        • Teva Investigational Site 31004
  • Ukraine
      • Cherkasy, Ukraine
        • Teva Investigational Site 58011
      • Dnipropetrovsk, Ukraine
        • Teva Investigational Site 58013
      • Donetsk, Ukraine
        • Teva Investigational Site 58014
      • Khmelnytskyi, Ukraine
        • Teva Investigational Site 58017
      • Kyiv, Ukraine
        • Teva Investigational Site 58010
      • Kyiv, Ukraine
        • Teva Investigational Site 58012
      • Kyiv, Ukraine
        • Teva Investigational Site 58015
      • Simferopol, Ukraine
        • Teva Investigational Site 58016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newly diagnosed subjects with a confirmed pathologic diagnosis of diffuse large B cell non-Hodgkin's lymphoma (DLBCL) based on the 2008 World Health Organization classification.

    2.CD20+ lymphoma cells at screening

  • 18-80 (inclusive) years of age at screening
  • Ann Arbor Stages I-IV at screening
  • Any IPI score at screening
  • ECOG good performance status (0-2) at screening
  • Willing and able to provide written informed consent prior to performing study procedures
  • Women of childbearing potential must use effective contraceptive methods starting from screening and until 12 months following the last infusion..

Exclusion Criteria:

  1. Any lymphoma other than CD20+ DLBCL
  2. History of indolent lymphoma
  3. DLBCL with central nervous system or meningeal involvement
  4. Primary gastrointestinal (MALT) lymphoma
  5. Bulky disease>10 cm diagnosed by imaging at screening
  6. Bone marrow involvement > 25% according to bone marrow biopsy at screening
  7. Subjects previously treated with chemotherapy, radiotherapy, immunotherapy or experimental therapies for lymphoma or other malignancy
  8. Hypersensitivity to active ingredients, excipients (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections) and murine proteins
  9. Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
  10. A documented history of recurrent or chronic clinically significant infection (viral, bacterial or fungal infection)
  11. Subjects with a history of tuberculosis or active tuberculosis at screening.
  12. Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity
  13. Positive Hepatitis B surface antigen or antibodies to Hepatitis C
  14. History of other cancer within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of uterine cervix
  15. Any major surgical procedure within 12 weeks prior to screening and between screening and baseline
  16. Immunization with live viral vaccines less than 4 weeks prior to first study drug infusion, and/or planned live viral vaccination during study period.
  17. Known allergic reactions against foreign proteins

  18. Subjects for whom 8 cycles of CHOP might be problematic, and have the following findings/conditions, should not be enrolled:

    • Cardiac contra-indication to doxorubicin: Left ventricular ejection fraction (LVEF) < 50% according to multi-acquisition gated (MUGA) scan or 2D Echocardiogram at screening
    • Neurologic contra-indication to vincristine: (e.g., peripheral neuropathy)
    • Abnormal hepatic function at screening and/or baseline
    • AST/ALT ≥ 3 x upper normal value (ULN) or ≥ 5 x ULN in the presence of DLBCL involvement of the liver
    • Bilirubin ≥ 2 x ULN or ≥ 5 x ULN in the presence of DLBCL involvement of the liver
    • Abnormal renal function at screening and/or baseline
    • Serum creatinine ≥ 2 x ULN
    • Abnormal bone marrow function at screening and/or baseline
    • Platelets < 100x109/L
    • Neutrophils < 1.5x109/L
    • Hb < 9g/dL
  19. Any other serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the Investigator Brochure of TL011)
  20. Subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study.
  21. Pregnant or lactating women or women that intend to get pregnant during study or within 12 months following the last infusion.
  22. Treatment with any investigational drug within 90 days before planned first cycle of chemotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: TL011
Biological: TL011
375 mg/m2 iv every 3 weeks for 8 cycles
ACTIVE_COMPARATOR: MabThera®
Biological: Rituximab
375 mg/m2 iv every 3 weeks for 8 cycles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
AUC during a dosing interval for Rituximab
Time Frame: 21 weeks
21 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
PK and PD parameters
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mariano Provencio, MD, PhD, Hospital Universitario Puerta De Hierro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NHL-TL011-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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