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IPH2102

Phase 2

Acute Myeloid Leukemia | Small molecule | Oncology |Innate Pharma S.A.|Last Updated: Feb 8, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment152

FDA Designations

No designations recorded

Clinical trial landscape

IPH2102 · 1 trial · 1 indication

Phase 2 1
NCT01687387Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR)Acute Myeloid Leukemia
COMPLETED152 Analytics
PHASE2COMPLETED
Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR)
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Leukemia-Free Survival
from date of randomization until the date of first documented relapse, assessed up to 48 months

Secondary Endpoints

Number of Participants With Adverse Events
from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit, up to 24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IPH2102 at 1 mg/kgEXPERIMENTALlirilumab (IPH2102/BMS986015) at 1 mg/kg
IPH2102 at 0.1 mg/kgEXPERIMENTALlirilumab (IPH2102/BMS986015) at 0.1 mg/kg
Placebo (Normal saline solution)PLACEBO_COMPARATORNormal saline solution

Interventions

NameTypeDescription
IPH2102 at 0.1 mg/kgDRUGevery 3 months
IPH2102 at 1 mg/kgDRUGevery 4 weeks
Placebo (normal saline solution)DRUGevery 4 weeks
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Eligibility Criteria

Age Range60 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites43

Inclusion Criteria: 1. Primary or secondary Acute Myeloid Leukemia (AML, defined according to WHO 2008 criteria), in first CR/CRi (according to the revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Stand...

Countries:France
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