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Venetoclax monotherapy

Phase 2

Chronic Lymphocytic Leukemia (CLL) | Small molecule | Oncology |Adaptive Biotechnologies Corporation|Last Updated: Jan 29, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment81
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04419519Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With VenetoclaxPHASE2 ACTIVE NOT_RECRUITING 81May 13, 2020May 1, 2027Jan 29, 20269 United States
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Study Endpoints
Primary Endpoints
Proportion of patients able to remain off CLL/SLL directed therapy
2 years

This will be described as a percentage of all patients with available data at 12 cycles of follow up (evaluable population).

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Venetoclax monotherapyEXPERIMENTAL -
Venetoclax with anti-CD20 monoclonal antibodyEXPERIMENTAL -
Interventions
NameTypeDescription
Venetoclax monotherapyDRUGVenetoclax monotherapy
Venetoclax with anti CD20 monoclonal antibodyDRUGVenetoclax with anti CD20 monoclonal antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Screening Phase Inclusion Criteria: * ≥ 18-years-old * Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma confirmed by the enrolling institution * Receiving treatment or planning to receive treatment within 30 days with a venetoclax-based regimen as defined below: * Venetocl...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04419519studyFirstPostDate: changed