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

Alternate Title

Phase II Study of Oblimersen and Imatinib Mesylate in Patients With Imatinib Mesylate-Resistant Chronic Myelogenous Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	15 and over	NCI	CALGB-10107 NCT00049192

Trial Description

Purpose:

Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Oblimersen may help imatinib mesylate kill more cancer cells by making cancer cells more sensitive to the drug.

Phase II trial to study the effectiveness of combining oblimersen with imatinib mesylate in treating patients who have chronic myelogenous leukemia that has not responded to previous treatment with imatinib mesylate.

Eligibility:

Eligibility criteria include the following:

• At least 15 years old
• Must be enrolled in clinical trials CLB-9665 and CLB-29801
• No previous stem cell transplantation
• At least 4 weeks since interferon, hydroxyurea, homoharringtonine, cytarabine, or anagrelide
• 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 receive a 10-day continuous infusion of oblimersen. They will also receive imatinib mesylate by mouth once or twice a day. Treatment may be repeated every 3 weeks for up to four courses. Some patients may continue to receive imatinib mesylate alone once a day. Patients will be evaluated once a month for 3 months and every 3 months for 5 years.

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

Cancer and Leukemia Group B

Meir Wetzler, MD, Protocol chair		Ph: 716-845-8447; 800-685-6825 Email: meir.wetzler@roswellpark.org

Registry Information
Official Title		A Phase II Study of G3139 (Genasense, NSC #683428 IND #58842) + Imatinib Mesylate (Gleevec, STI571) in Patients with Imatinib-Resistant Chronic Myeloid Leukemia
Trial Start Date		2002-11-15
Trial Completion Date		2008-08-28
Registered in ClinicalTrials.gov		NCT00049192
Date Submitted to PDQ		2002-09-05
Information Last Verified		2004-11-22
NCI Grant/Contract Number		CA31946

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