Name of the Trial
Phase III Randomized Study of Induction Therapy Comprising Cytarabine and Daunorubicin with versus without Gemtuzumab Ozogamicin followed by Consolidation Therapy Comprising High-Dose Cytarabine and Post-Consolidation Therapy Comprising Gemtuzumab Ozogamicin versus No Additional Therapy in Patients with Previously Untreated De Novo Acute Myeloid Leukemia (SWOG-S0106). See the protocol abstract at http://cancer.gov/clinicaltrials/SWOG-S0106.

Principal Investigator
Dr. Stephen Petersdorf, Southwest Oncology Group

Why Is This Trial Important?
Acute myeloid leukemia (AML) is one of the most aggressive forms of leukemia (cancer of the blood) in adults. Initial treatment for AML usually involves sequential, combination chemotherapy designed first to induce or bring about a remission (induction chemotherapy) and second to keep the cancer in remission and prevent a relapse (consolidation or post-remission therapy).

In this trial, researchers are testing whether addition of an immunotoxin, gemtuzumab ozogamicin, to standard chemotherapy will improve the disease-free survival of patients with previously untreated AML. Gemtuzumab ozogamicin is a monoclonal antibody linked to a powerful bacterial toxin. The monoclonal antibody can locate and bind to leukemia cells and deliver the toxin to them. Patients may receive standard therapy alone or gemtuzumab ozogamicin during induction chemotherapy, after consolidation chemotherapy (post-consolidation therapy), or both.

"In phase II studies, treatment including gemtuzumab ozogamicin led to promising remission rates for patients with AML," said Dr. Petersdorf. "We haven't seen any significant improvements in remission rates for AML in many years, so it is important that we confirm those findings with a large phase III trial."

Who Can Join This Trial?
Researchers seek to enroll 684 patients aged 18 to 55 with previously untreated de novo AML. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/SWOG-S0106.

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/SWOG-S0106.

Contact Information
See the list of study contacts at http://cancer.gov/clinicaltrials/SWOG-S0106 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.

An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.