Name of the Trial
Phase III Randomized Study of Daunorubicin and Cytarabine with or without Oblimersen in Older Patients with Previously Untreated Acute Myeloid Leukemia (CALGB-10201). See the protocol abstract at http://cancer.gov/clinicaltrials/CALGB-10201.

Principal Investigator
Dr. Guido Marcucci, Cancer and Leukemia Group B

Why Is This Trial Important?
Acute myeloid leukemia (AML) is the most common type of blood and bone marrow cancer in U.S. adults. Treatment of newly diagnosed AML usually involves chemotherapy to induce a remission of the cancer (induction therapy), followed by more chemotherapy to keep the cancer in remission and prevent a relapse (consolidation or post-remission therapy).

In this trial, researchers are trying to determine whether adding the drug oblimersen (Genasense) to chemotherapy will improve survival in patients aged 60 and older who have previously untreated AML. Oblimersen blocks production of a protein called Bcl-2, which helps cancer cells survive. Bcl-2 is overexpressed in many types of tumors and contributes to cancer cell resistance to chemotherapy. By blocking production of Bcl-2, oblimersen may make cancer cells more susceptible to the cytotoxic effects of chemotherapy.

"Although AML long-term remission rates in younger patients are better, the long-term remission rates for AML in patients over 60 years old are very low, about 10-15 percent," said Dr. Marcucci. "AML is prevalent in the geriatric population in America, and as that population continues to grow, we can expect to see an increase in the number of older Americans with AML.

"That is why we need to come up with a new approach for treating AML in older patients," Dr. Marcucci added.

Who Can Join This Trial?
Researchers seek to enroll 500 patients aged 60 and older with a confirmed diagnosis of AML who have not yet received treatment for their disease. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/CALGB-10201.

Where Is This Trial Taking Place?
Multiple study sites in the United States are recruiting patients for this trial. See the list of study sites at http://cancer.gov/clinicaltrials/CALGB-10201.

Contact Information
See the list of study contacts at http://cancer.gov/clinicaltrials/CALGB-10201 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.