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Venetoclax

Phase 1

Lymphoma, B-Cell | Small molecule | Oncology |Incyte Corporation|Last Updated: May 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04161248Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell LymphomaEARLY_PHASE1 ACTIVE NOT_RECRUITING 40Sep 2, 2020Dec 31, 2026May 12, 20264 Canada
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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 — 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 4 trials
Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT04161248Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT04161248studyFirstPostDate: changed