Clinical trialNCT00372593CompletedPhase 3Interventional

Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia

SponsorChildren's Oncology GroupEnrollment1,070Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with gemtuzumab may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab in treating patients with newly diagnosed acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy and gemtuzumab to see how well they work compared with combination chemotherapy alone in treating young patients with newly diagnosed acute myeloid leukemia.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Alan S. Gamis, MD, MPH
Children's Mercy Hospital Kansas City
Study Chair
clinicaltrials.gov ↗
Richard Aplenc, MD, MSCE
Children's Hospital of Philadelphia
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

198 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, Australia
Royal Children'S Hospital
Herston, Queensland, Australia
Women'S and Children'S Hospital
North Adelaide, South Australia, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia

Canada

Children'S & Women'S Hospital of British Columbia
Vancouver, British Columbia, Canada
Cancercare Manitoba
Winnipeg, Manitoba, Canada
Janeway Children'S Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada
Iwk Health Centre
Halifax, Nova Scotia, Canada
Mcmaster Children'S Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Children'S Hospital of Western Ontario
London, Ontario, Canada
Children'S Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Canada

New Zealand

Christchurch Hospital
Christchurch, New Zealand
Starship Children'S Health
Grafton, New Zealand

Puerto Rico

San Jorge Children'S Hospital
Santurce, Puerto Rico

Switzerland

Swiss Pediatric Oncology Group Bern
Bern, Switzerland
Swiss Pediatric Oncology Group Geneva
Geneva, Switzerland

United States

Uab Comprehensive Cancer Center
Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Banner Desert Medical Center
Mesa, Arizona, United States
Phoenix Children'S Hospital
Phoenix, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at Ucla
Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States
Children'S Hospital Central California
Madera, California, United States
Children'S Hospital and Research Center Oakland
Oakland, California, United States
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States
Children'S Hospital of Orange County
Orange, California, United States
Sutter Cancer Center
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Rady Children'S Hospital - San Diego
San Diego, California, United States
Ucsf Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States

158 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AsparaginaseCytarabine →DaunorubicinEtoposide →Gemtuzumab ozogamicin →Mitoxantrone

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Aug 2006
Primary completion: 31 Aug 2013
Completion: 30 Sept 2020
Last update posted: 24 Mar 2021
Registered enrollment: 1,070
Registry id: NCT00372593

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.