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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Standard Induction Chemotherapy With or Without Gemtuzumab Ozogamicin in Elderly Patients With Previously Untreated Acute Myeloid Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	61 to 75	Other	EORTC-06012 AML-17, NCT00052299, GIMEMA-AML-17

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combining combination chemotherapy with monoclonal antibody therapy will kill more cancer cells.

Randomized phase III trial to determine the effectiveness of combination chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute myeloid leukemia.

Eligibility:

Eligibility criteria include the following:

• 61-75 years old
• No previous treatment for this cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Patients in group one will receive a 2-hour infusion of gemtuzumab ozogamicin on days 1 and 15. Beginning approximately 7 weeks later, they will receive infusions of combination chemotherapy for 1 week; bone marrow will be evaluated 3 weeks later. This treatment may be repeated. After 4 weeks, patients will receive a different combination chemotherapy regimen for 5 days. This treatment may be repeated after 1 month. Patients in group two will not receive gemtuzumab ozogamicin but will receive combination chemotherapy and bone marrow assessment as in group one. All patients will be evaluated once a month for 1 year, every 3 months for 2 years and every 6 months thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Sergio Amadori, MD, Study coordinator		Ph: 39-06-591-4745 Email: mc7673@mclink.it

Gruppo Italiano Malattie Ematologiche dell’Adulto

Sergio Amadori, MD, Protocol chair		Ph: 39-06-591-4745 Email: mc7673@mclink.it

Registry Information
Official Title		Gemtuzumab Ozogamicin (GO) Combined With Standard Intensive Chemotherapy Versus Standard Intensive Chemotherapy Alone For Induction/Consolidation In Patients 61-75 Years Old With Previously Untreated AML: A Randomized Phase III Trial (AML-17) Of The EORTC-LG and the GIMEMA-ALWP
Trial Start Date		2002-09-25
Registered in ClinicalTrials.gov		NCT00052299
Date Submitted to PDQ		2002-09-27
Information Last Verified		2006-11-19

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