Completed PHASE3 INTERVENTIONAL 2-arm NCT00927498

A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old

A Phase III Multicentric Randomized Study of the Combination of Repeated Doses of Gemtuzumab Ozogamicin (GO) With Daunorubicin and Cytarabine Versus Daunorubicin and Cytarabine in Untreated Patients With Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old.

Sponsor: Acute Leukemia French Association

Conditions Acute Myeloid Leukemia

Interventions Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin), conventional chemotherapy (AraC + Daunorubicin),

Updated 6 times since 2017 Last updated: Jul 10, 2013 Started: Dec 31, 2007 Primary completion: Jul 31, 2011 Completion: Jul 31, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Acute Myeloid Leukemia and is currently completed. Acute Leukemia French Association leads this study, which shows 6 recorded versions since 2007 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Dec 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Acute Leukemia French Association
Versailles Hospital

Data source: Acute Leukemia French Association

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Argenteuil, France , Bobigny, France , Caen, France , Clamart, France , Créteil, France , Dijon, France , Lens, France , Lille, France , Limoges, France , Lyon, France and 8 more locations