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Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML

NCT04168502 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2024-11-08

No results posted yet for this study

Summary

MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD.

Conditions

Interventions

DRUG

Gemtuzumab Ozogamicin

Patients will receive induction and consolidation with Gemtuzumab ozogamicin, Daunorubicin and Cytarabine

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2025-04-30
Completion
2027-04-30

Countries

  • Italy

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 NCT04168502 on ClinicalTrials.gov