Clinical trial

Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients…

NCT00372593 · Children's Oncology Group, Other · Completed

Key facts

NCT number NCT00372593
Title Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia
Official title A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults
Lead sponsor Children's Oncology Group, Other
Collaborators National Cancer Institute (NCI) NIH
Status Completed
Phase Phase 3
Study type Interventional
Conditions Leukemia
Intervention type Drug
Interventions asparaginase, cytarabine, daunorubicin hydrochloride, etoposide, gemtuzumab ozogamicin, mitoxantrone hydrochloride
Enrollment 1,070
Start date Aug 1, 2006
Primary completion Aug 1, 2013
Completion Sep 30, 2020
First posted Sep 7, 2006
Last update posted Mar 24, 2021
Countries Australia, Canada, New Zealand, Puerto Rico, Switzerland, United States

At a glance

  • 100–999 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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