Gemtuzumab Ozogamicin (GO) monotherapy versus standard supportive care for previously untreated AML in elderly patients who are not eligible for intensive chemotherapy: a randomized phase II/III trial (AML-19)of the EORTC-LG and GIMEMA-ALWP

Gemtuzumab Ozogamicin (GO) monotherapy versus standard supportive care for previously untreated AML in elderly patients who are not eligible for intensive chemotherapy: a randomized phase II/III trial (AML-19)of the EORTC-LG and GIMEMA-ALWP - GIMEMA AML19 (EORTC 06031)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004356-39-IT

Enrollment

259

Registered

2005-05-18

Start date

2005-05-16

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly patients (61-75 years not eligible for intensive chemotherapy

Interventions

Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Gemtuzumab Concentration unit: mg milligram(s) Concentration number: 5-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: ;Secondary Objective: ;Primary end point(s):	—

Countries

Italy

Contacts

Public ContactCentro Dati

Fondazione GIMEMA Onlus

gimema@gimema.it06-70390526

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026