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Dose-escalating Phase I Trial With GEM333 in Patients With Acute Myeloid Leukemia

NCT03516760 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-09-29

No results posted yet for this study

Summary

This dose-escalating phase I trial assesses for the first time the safety, the side effects and the harmlessness, as well as the therapeutical benefit of the new study drug GEM333 in patients with acute myeloid leukemia (AML). This AML was relapsed after previous therapy or was refractory to the standard therapy.

Conditions

Interventions

DRUG

GEM333

infusion of GEM333; administered intravenously and continuously over 10 days

Sponsors & Collaborators

  • GCP-Service International Ltd. & Co. KG

    collaborator INDUSTRY

  • AvenCell Europe GmbH

    lead INDUSTRY

Principal Investigators

  • Martin Wermke, MD · Universitätsklinikum Carl Gustav Carus Dresden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-11
Primary Completion
2022-06-14
Completion
2022-06-14

Countries

  • Germany

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 NCT03516760 on ClinicalTrials.gov