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Clinical Trials (PDQ®)

  • First Published: 6/1/2000
  • Last Modified: 7/15/2009

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Clinical Trials (PDQ®)

Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

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

Alternate Title

Phase III Randomized Study of Intensive Versus Nonintensive Chemotherapy in Older Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed60 and overOtherLRF-AML14
EU-20016, NCT00005823, ISRCTN62207270

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if stronger doses of chemotherapy given over a longer period of time are as well tolerated or as effective as less intensive chemotherapy.

This randomized phase III trial is studying intensive regimens of chemotherapy to see how well they work compared to nonintensive regimens of chemotherapy in treating older patients with acute myeloid leukemia or myelodysplastic syndrome.

Eligibility:

Eligibility criteria include the following:

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 treatment groups. Patients in group one will receive intensive chemotherapy treatment consisting of infusions of daunorubicin and cytarabine plus thioguanine by mouth for up to four courses. Some patients may receive infusions of PSC 833, mitoxantrone, idarubicin, and etoposide. Patients in group two will receive either hydroxyurea by mouth or injections of cytarabine with or without tretinoin by mouth for up to 16 weeks. Quality of life will be assessed periodically. Patients will receive follow-up evaluations at 1 year.

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

Leukemia Research Fund

Alan Burnett, MD, FRCP, Protocol chair
Ph: 44-29-2074-2375
Email: burnettak@cardiff.ac.uk

Registry Information
Official Title A Randomized Trial for Patients with Acute Myeloid Leukemia or High Risk Myelodysplatic Syndrome Aged 60 or Over
Trial Start Date 1998-12-01
Registered in ClinicalTrials.gov NCT00005823
Date Submitted to PDQ 2000-03-23
Information Last Verified 2006-09-17

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