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Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR)

NCT01687387 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2019-02-08

Study results available
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Summary

Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute Myeloid Leukemia (AML) in first complete remission

Conditions

Interventions

DRUG

IPH2102 at 0.1 mg/kg

every 3 months

DRUG

IPH2102 at 1 mg/kg

every 4 weeks

DRUG

Placebo (normal saline solution)

every 4 weeks

Sponsors & Collaborators

  • Innate Pharma

    lead INDUSTRY

Principal Investigators

  • Norbert Vey, MD · Institut Paoli Calmettes Marseille France

  • Hervé Dombret, MD · ALFA cooperative Group

  • Norbert Ifrah, MD · GOELAMS Cooperative Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-11-17
Completion
2016-11-17

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01687387 on ClinicalTrials.gov