NCT01205737

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2010

Typical duration for phase_1

Geographic Reach
9 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

2.8 years

First QC Date

September 17, 2010

Last Update Submit

October 21, 2013

Conditions

DLBCL

Keywords

DLBCLpharmacokineticspharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • AUC during a dosing interval for Rituximab

    21 weeks

Secondary Outcomes (1)

  • PK and PD parameters

    Throughout study

Study Arms (2)

TL011

EXPERIMENTAL
Biological: TL011

MabThera®

ACTIVE COMPARATOR
Biological: Rituximab

Interventions

TL011BIOLOGICAL

375 mg/m2 iv every 3 weeks for 8 cycles

TL011
RituximabBIOLOGICAL

375 mg/m2 iv every 3 weeks for 8 cycles

MabThera®

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • CD20+ lymphoma cells at screening
  • (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..

You may not qualify if:

  • Any lymphoma other than CD20+ DLBCL
  • History of indolent lymphoma
  • DLBCL with central nervous system or meningeal involvement
  • Primary gastrointestinal (MALT) lymphoma
  • Bulky disease\>10 cm diagnosed by imaging at screening
  • Bone marrow involvement \> 25% according to bone marrow biopsy at screening
  • Subjects previously treated with chemotherapy, radiotherapy, immunotherapy or experimental therapies for lymphoma or other malignancy
  • Hypersensitivity to active ingredients, excipients (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections) and murine proteins
  • Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
  • A documented history of recurrent or chronic clinically significant infection (viral, bacterial or fungal infection)
  • Subjects with a history of tuberculosis or active tuberculosis at screening.
  • Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity
  • Positive Hepatitis B surface antigen or antibodies to Hepatitis C
  • History of other cancer within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of uterine cervix
  • Any major surgical procedure within 12 weeks prior to screening and between screening and baseline
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Teva Investigational Site 59005

Pleven, Bulgaria

Location

Teva Investigational Site 59003

Plovdiv, Bulgaria

Location

Teva Investigational Site 59001

Sofia, Bulgaria

Location

Teva Investigational Site 59002

Sofia, Bulgaria

Location

Teva Investigational Site 59004

Varna, Bulgaria

Location

Teva Investigational Site 55001

Tallinn, Estonia

Location

Teva Investigational Site 55002

Tartu, Estonia

Location

Teva Investigational Site 35066

Paris, France

Location

Teva Investigational Site 51026

Debrecen, Hungary

Location

Teva Investigational Site 30001

Florence, Italy

Location

Teva Investigational Site 30002

Napoli, Italy

Location

Teva Investigational Site 56002

Daugavpils, Latvia

Location

Teva Investigational Site 56001

Riga, Latvia

Location

Teva Investigational Site 56003

Riga, Latvia

Location

Teva Investigational Site 53010

Warsaw, Poland

Location

Teva Investigational Site 50011

Arkhangelsk, Russia

Location

Teva Investigational Site 50001

Chelyabinsk, Russia

Location

Teva Investigational Site 50006

Kazan', Russia

Location

Teva Investigational Site 50014

Kursk, Russia

Location

Teva Investigational Site 50005

Moscow, Russia

Location

Teva Investigational Site 50009

Moscow, Russia

Location

Teva Investigational Site 50010

Moscow, Russia

Location

Teva Investigational Site 50003

Novosibirsk, Russia

Location

Teva Investigational Site 50017

Pyatigorsk, Russia

Location

Teva Investigational Site 50012

Saint Petersburg, Russia

Location

Teva Investigational Site 50015

Tomsk, Russia

Location

Teva Investigational Site 50004

Yekaterinburg, Russia

Location

Teva Investigational Site 31005

Elche-Alicante, Spain

Location

Teva Investigational Site 31006

Las Palmas de Gran Canaria, Spain

Location

Teva Investigational Site 31002

Madrid, Spain

Location

Teva Investigational Site 31001

Majadahonda-Madrid, Spain

Location

Teva Investigational Site 31003

Valencia, Spain

Location

Teva Investigational Site 31004

Valencia, Spain

Location

Teva Investigational Site 58011

Cherkasy, Ukraine

Location

Teva Investigational Site 58013

Dnipropetrovsk, Ukraine

Location

Teva Investigational Site 58014

Donetsk, Ukraine

Location

Teva Investigational Site 58017

Khmelnytskyi, Ukraine

Location

Teva Investigational Site 58010

Kyiv, Ukraine

Location

Teva Investigational Site 58012

Kyiv, Ukraine

Location

Teva Investigational Site 58015

Kyiv, Ukraine

Location

Teva Investigational Site 58016

Simferopol, Ukraine

Location

MeSH Terms

Interventions

Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mariano Provencio, MD, PhD

    Hospital Universitario Puerta de Hierro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2010

First Posted

September 20, 2010

Study Start

September 1, 2010

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations

ES(2)BU(5)LA(3)UA(8)FR(1)RU(12)HU(1)IT(2)PL(1)