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A Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia

NCT01256073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-02-28

No results posted yet for this study

Summary

The trial is a multi-centre, open-label, safety and tolerability extension trial to the IPH2101-101 (previously NN1975-1733) first human dose trial completed with a larger subject pool at an optimal dose level. The trial is conducted in elderly Acute Myeloid Leukemia (AML) patients over the age of 60 years, in complete remission, and who are not eligible for allogeneic stem-cell transplantation. The dose given to the individual patient will be the same as the patient received in the single dose trial IPH2101-101 and 1 mg/kg or 2 mg/kg for the 12 patients in an additional cohort.

Conditions

Interventions

DRUG

IPH2101

IPH2101 fully human anti-KIR monoclonal antibody

Sponsors & Collaborators

  • Innate Pharma

    lead INDUSTRY

Principal Investigators

  • Norbert Vey, MD · Institut Paoli Calmettes Marseille France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2013-07-31
Completion
2013-09-30

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 NCT01256073 on ClinicalTrials.gov