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PEG-asparaginase

Phase 2

Acute Lymphoblastic Leukemia | Small molecule | Oncology |Sanofi|Last Updated: Mar 30, 2017

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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00973752Treatment of Older Adults With Acute Lymphoblastic LeukemiaPHASE2 COMPLETED 30Aug 1, 2009Apr 1, 2016Mar 30, 20173 United States
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Study Endpoints
Primary Endpoints
Overall Survival at One Year
1 years

The number of participants alive one year after baseline.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ExperimentalEXPERIMENTALAll patients treated on same arm
Interventions
NameTypeDescription
PrednisoneDRUGOrally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.
VincristineDRUGIntravenously during Induction, CNS, Consolidation 2 and Continuation Therapy
DoxorubicinDRUGIntravenously during Induction, CNS, and Consolidation 2 therapy
PEG-asparaginaseDRUGIntravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy
CytarabineDRUGIntrathecally during Induction and CNS therapy
MethotrexateDRUGIntrathecally during Induction, CNS, and Continuation Therapy
ImatinibDRUGOrally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy
ClofarabineDRUGIntravenously during Consolidation 1 Therapy
6 MercaptopurineDRUGOrally during CNS, Consolidation 2 and Continuation Therapy
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Eligibility Criteria
Age Range51 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Acute lymphoblastic leukemia, excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8). * Patients with mature B-cell ALL will be removed from the protocol as soon as the diagnosis is...

Countries:United States
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