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Re-Induction Phase

Phase 2

Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia | Small molecule | Oncology |Novartis AG|Last Updated: May 6, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment55
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06773936Adding Asciminib to Usual Treatment for Adults With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic LeukemiaPHASE2 ENROLLING BY_INVITATION 55May 15, 2026Jul 1, 2033May 6, 20268 United States
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Study Endpoints
Primary Endpoints
Major molecular remission by polymerase chain reaction for BCR-ABL
Up to 100 days after treatment start

Major molecular remission (MMR), also known as MR3.0, is defined as BCR-ABL transcript levels (expressed as a percentage compared with the ABL control gene) ≤ 0.1% based on PCR at day 85.

Secondary Endpoints
Rate of Complete Remission (with and without complete count recovery, CR/CRi)
Up to 100 days after treatment start
Disease-free Survival
Up to 5 years.
Overall Survival
Up to 5 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Interventions
NameTypeDescription
Induction PhaseDRUGAsciminib, Dasatinib, Prednisone, and Methotrexate
Re-Induction PhaseDRUGBlinatumomab, Dasatinib, Methotrexate, and Dexamethasone
Post-RemissionDRUGBlinatumomab, Dasatinib, Methotrexate and Dexamethasone
MaintenanceDRUGAsciminib, Dasatinib, Prednisone, and Methotrexate
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Participants must have a new diagnosis of Philadelphia chromosome positive (Ph+) ALL by cytogenetics, FISH, or polymerase chain reaction (PCR). Diagnostic specimens must be submitted to the site's local CLIA-approved cytogenetics laboratory and results (cytogenetics, FISH, or ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06773936studyFirstPostDate: changed