Study on Azacitidine and Gemtuzumab Ozogamicin for Older Patients with Untreated Acute Myeloid Leukemia

Program Overview

This study is exploring the effects of combining azacitidine and gemtuzumab ozogamicin to treat older patients with acute myeloid leukemia (AML) who have not been treated before. Azacitidine is a chemotherapy drug that stops cancer cells from growing by killing them or preventing them from dividing. Gemtuzumab ozogamicin is a monoclonal antibody that can block cancer growth by finding and killing cancer cells or delivering cancer-killing substances to them. The study aims to see if using these two drugs together can kill more cancer cells.

Description

The main goals of this study are to see if the combination of azacitidine and gemtuzumab ozogamicin is effective enough to be tested in a larger phase III trial, to understand the side effects in different risk groups, and to see how long patients stay free of disease after achieving remission. The study will also look at how genetic changes in cancer cells affect treatment outcomes.

Patients are divided into groups based on their risk status. Those in the study will receive azacitidine either through an IV or under the skin for seven days, followed by gemtuzumab ozogamicin through an IV on the eighth day. If leukemia remains, a second round of treatment may be given. Patients who achieve remission will receive further treatment to consolidate their remission.

After the initial treatment, patients will receive maintenance therapy with azacitidine for four cycles, each lasting 28 days, unless the disease progresses or side effects become unacceptable. Bone marrow biopsies will be conducted at various stages to study genetic changes.

After completing the study treatment, patients will be monitored regularly for several years to track their health and any recurrence of leukemia.

Eligibility Criteria

Locations