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Adcetris-Levact

Phase 1

Clinical Efficacy | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jan 4, 2023

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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02467946Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old PatientPHASE1 COMPLETED 60Jan 14, 2016Apr 6, 2022Jan 4, 20231 France
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Study Endpoints
Primary Endpoints
toxicity analysis
up to 2.5 years

To evaluate the tolerability and toxicity of Adcetris-Levact (BV-Be) association.

Efficacy analysis
up to 2.5 years

To evaluate the efficacy in terms of Response Rate after treatment completion of Adcetris-Levact (BV-Be) association.

Secondary Endpoints
Progression Free Survival
3 years
Complete Response Rate
2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Adcetris-Levact (BV-Be) AssociationEXPERIMENTALAdcetris® (BV) : 1.2 mg/kg intravenously every 3 weeks Levact® (Be): 90 mg/m2/day intravenously for 2 days every 3 weeks. Up to 6 cycles
Interventions
NameTypeDescription
Adcetris-LevactDRUGAssociation of Adcetris (1.2 mg/kg intravenously every 3 weeks) with Levact (90 mg/m2/day intravenously for 2 days every 3 weeks) during at least 6 cycles.
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Eligibility Criteria
Age Range60 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification. All Hasenclever IPS prognostic groups accepted 2. Stages IIB to IV B 3. Age 60-80 years included 4. Patient not previously treated 5. ECOG ≤ 2 6. Patient with adequate...

Countries:France
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