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Venetoclax

Phase 1

Lymphoma, B-Cell | Small molecule | Oncology |Incyte Corporation|Last Updated: Jun 24, 2026

Target and mechanism

Molecular targetBCL2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Venetoclax · 1 trial · 1 indication

Early Phase 1 1
NCT04161248Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell LymphomaLymphoma, B-Cell
ACTIVE NOT_RECRUITING40 Analytics
EARLY_PHASE1ACTIVE NOT_RECRUITING
Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma
Lymphoma, B-CellUnlock trial analytics

Study Endpoints

Primary Endpoints

Establish maximum tolerated dose of new combination therapy
4 years
Establish recommended Phase II dose of new combination therapy
4 years

Secondary Endpoints

Overall response rate using RECIL response criteria
4 years
Overall response rate using the Lugano response criteria
4 years
Severity of adverse events using CTCAE
4 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Venetoclax + R-GDPEXPERIMENTAL -
Glofitamab + R-GDPEXPERIMENTAL -
Tafasitamab + R-GDPEXPERIMENTAL -

Interventions

NameTypeDescription
VenetoclaxDRUGDose Level -1: Venetoclax 200 mg/day days 4-8 cycle 1, days 1-5 cycle 2 and 3, + R-GDP Dose Level 1: Venetoclax 200 mg/day days 4-10 cycle 1, days 1-10 cycle 2 and 3, + R-GDP Dose Level 2: Venetoclax 400 mg/day days 4-10 cycle 1, days 1-10 cycle 2 and 3, + R-GDP Dose Level 3: Venetoclax 800 mg/day days 4-10 cycle 1, days 1-10 cycle 2 and 3, + R-GDP
Rituximab InjectionDRUG375 mg/m2 - Day 1, cycle 1.
Rituximab SCDRUG1400 mg fixed dose - Day 1, cycle 2 and 3
GemcitabineDRUG1000 mg/m2 - Day 1 to day 8
DexamethasoneDRUG40 mg daily - Day 1 to day 4
CisplatinDRUG75mg/m2 - Day 1
GlofitamabDRUGCycle 1: Glofitamab 2.5 mg (day 8) and 10 mg (day 15) + R-GDP Cycle 2: Glofitamab 30 mg (day 8) + R-GDP Cycle 3: Glofitamab 30 mg (day 8) + R-GDP
TafasitamabDRUGCycle 1: Tafasitamab (12 mg/kg IV day -1, 8, 15) Cycles 2 and 3: Tafasitamab (12 mg/kg IV day 1, 8, 15)
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Eligibility Criteria

Age Range16 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Patients with histologic diagnosis for one of the following histologies according to the World Health Organization: documented at initial diagnosis or at relapse: * Diffuse large cell lymphoma, B-cell (includes primary mediastinal B-cell lymphoma, T-cell rich B-cell lymphom...

Countries:Canada
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Competitive Landscape -Cutaneous T-Cell Lymphoma 3 trials (matched to "Lymphoma, B-Cell")

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Recent Changes (Last 90 Days)

LOWJun 24, 2026NCT04161248lastUpdatePostDate: changed
LOWJun 24, 2026NCT04161248lastUpdatePostDate: changed

Frequently asked questions about Venetoclax

What is Venetoclax used for in B-Cell lymphoma?

Venetoclax is an investigational small molecule being studied for the treatment of relapsed or refractory aggressive B-Cell lymphoma. It is currently in early Phase 1 clinical development as part of a combination therapy master protocol for patients with this condition.

Who is developing Venetoclax?

Venetoclax is being developed by Incyte Corporation, which trades under the ticker INCY. The company is conducting clinical research on this drug for B-Cell lymphoma as part of its oncology pipeline.

What phase is Venetoclax in?

Venetoclax is in Phase 1 clinical development. It is currently being evaluated in an early Phase 1 trial for patients with relapsed or refractory aggressive B-Cell lymphoma, and it remains an investigational drug that has not been approved.

What clinical trials is Venetoclax in?

Venetoclax is being studied in a single clinical trial with the identifier NCT04161248. This trial is a Phase I master protocol of novel combination therapy for patients with relapsed or refractory aggressive B-Cell lymphoma, and it is active but not recruiting participants.

Is Venetoclax the same as any other drug?

Venetoclax is a distinct investigational drug being developed by Incyte Corporation for B-Cell lymphoma. It is not known to be identical to any other marketed or investigational agent, and it is being studied as a novel combination therapy component.