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TL011

Phase 1

DLBCL | Monoclonal antibody | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Oct 22, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment186

FDA Designations

No designations recorded

Clinical trial landscape

TL011 · 1 trial · 1 indication

Phase 1 1
NCT01205737A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma SubjectsDLBCL
COMPLETED186 Analytics
PHASE1COMPLETED
A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects
DLBCLUnlock trial analytics

Study Endpoints

Primary Endpoints

AUC during a dosing interval for Rituximab
21 weeks

Secondary Endpoints

PK and PD parameters
Throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TL011EXPERIMENTAL -
MabThera®ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
TL011BIOLOGICAL375 mg/m2 iv every 3 weeks for 8 cycles
RituximabBIOLOGICAL375 mg/m2 iv every 3 weeks for 8 cycles
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites41

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 St...

Countries:BulgariaEstoniaFranceHungaryItalyLatviaPolandRussiaSpainUkraine
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Frequently asked questions about TL011

What is TL011 used for in DLBCL?

TL011 is an investigational monoclonal antibody being studied for the treatment of diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin's lymphoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does TL011 target?

TL011 targets CD20, a protein found on the surface of B-cells. The clinical trial for TL011 specifically enrolled subjects with CD20-positive diffuse B-cell non-Hodgkin's lymphoma, indicating that the drug is designed to bind to this antigen on malignant B-cells.

Who makes TL011?

TL011 is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker symbol TEVA. The company is conducting clinical research to evaluate the safety and efficacy of this investigational monoclonal antibody.

What phase is TL011 in?

TL011 is in Phase 1 clinical development. The drug is investigational and has not yet received approval from regulatory agencies. It is being studied in a completed Phase 1 trial that enrolled 186 participants with DLBCL.

What clinical trials is TL011 in?

TL011 has one completed clinical trial registered under NCT01205737. This was a double-blind, randomized, active-controlled Phase 1 study in subjects with CD20-positive diffuse B-cell non-Hodgkin's lymphoma, conducted across multiple countries including Bulgaria, France, Hungary, Italy, and Russia.

Is TL011 the same as rituximab?

TL011 is not the same as rituximab, though both are monoclonal antibodies targeting CD20. The clinical trial for TL011 used an active control, meaning it was compared against an existing treatment, but the specific comparator is not identified in the available information.