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Adcetris-Levact

Phase 1

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

Success Probability

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Adcetris-Levact · 1 trial · 2 indications

Phase 1 1
NCT02467946Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old PatientClinical Efficacy
COMPLETED60 Analytics
PHASE1COMPLETED
Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old Patient
Clinical EfficacyUnlock trial analytics

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 to 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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Frequently asked questions about Adcetris-Levact

What is Adcetris-Levact used for?

Adcetris-Levact is a combination therapy being studied for the treatment of Hodgkin lymphoma in older patients. It is currently in Phase 1 clinical development, with a completed trial evaluating its clinical efficacy and safety in patients aged 60 years and older.

Who makes Adcetris-Levact?

Adcetris-Levact is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this combination therapy for Hodgkin lymphoma.

What phase is Adcetris-Levact in?

Adcetris-Levact is in Phase 1 clinical development. It is an investigational combination therapy and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains in early-stage clinical research.

What clinical trials is Adcetris-Levact in?

Adcetris-Levact has one completed clinical trial registered as NCT02467946, titled "Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old Patient." This Phase 1 study enrolled 60 participants in France and evaluated the combination's efficacy and safety.

Is Adcetris-Levact the same as Adcetris or Levact?

Adcetris-Levact is a combination therapy that includes Adcetris and Levact as its components. It is studied as a combined treatment regimen for Hodgkin lymphoma, distinct from either drug used alone.