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Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia

NCT02353143 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-08-12

Study results available
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Summary

The purpose of this study is to assess the safety of MEN1112, given as intravenous infusion, in patients with relapsed or refractory AML. Pharmacokinetics, clinical activity and potential immunogenicity of MEN1112 will be evaluated as well.

Conditions

  • Recurrent Adult Acute Myeloid Leukemia
  • Acute Myeloid Leukemia, in Relapse

Interventions

DRUG

MEN1112

Intravenous infusion of MEN1112 pro/Kg body weight dose will be administered for two 21-day cycles; MEN1112 dose is administered as' one shot infusion' (first group of patients) and as a dose to be infused in 3 days for the first two doses in Cycle 1 (second group of patients). Two treatment cycles will be followed by a 4-week End of Treatment Period and a Follow-up period. The individual treatment/observation period is six months (except for female patients of childbearing potential that will undergo monthly pregnancy test until 6 months from the last study drug administration).

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Adriano Venditti, Professor, MD · Hematology Department, "Tor Vergata" University Viale Oxford, 81 00133 Rome, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2021-04-09
Completion
2021-04-09

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Spain

Study Locations

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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 NCT02353143 on ClinicalTrials.gov