Clinical Research Details
Title:
A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin as Induction and Post-Remission Therapy in Participants Age 60 and Older with Previously Untreated Non-M3 Acute Myeloid Leukemia
Purpose:
The primary objective of this study is to test whether the induction regimen incorporating azacitidine and gemtuzumab ozogamicin is sufficiently safe and effective among older participants with previously untreated AML to warrant phase III study.
Study Number:
201404012109
Number of Patients:
139
Elgibility:
Adults = 60 years old must have:
• Morphologically confirmed diagnosis of acute leukemia (AML)
• Participants must not have received prior systemic chemotherapy for acute leukemia with the exception of hydroxyurea.
• Participants must have a bilirubin = 1.5 Institutional Upper Limit of Normal within 14 days prior to registration, unless the elevation is believed to be due to hepatic infiltration by AML.
• Participants must have SGOT = 1.5 x IULN or SGPT = 1.5 IULN or both within 14 days prior to registration, unless the elevation is believed to be due to hepatic infiltration by AML
• Participants must have a serum creatinine = 1.5 x IULN within 14 days prior to registration
• Participants must have an adequate cardiac function with left ventricular ejection fraction of = 40% (as determined by either MUGA or echocardiogram) and no clinical evidence of congestive heart failure
Treatment:
The study involves three phases of treatment: induction therapy, consolidation and maintenance therapy. During induction, you will receive injections of azacitidine and you will receive gemtuzumab ozogamicin intravenously. If your disease is in remission, you will move on to consolidation therapy and you will receive the same treatment you received during induction. If you are eligible for maintenance therapy, you will receive injections of azacitidine.
Principal Investigator:
Enrollment Phone:
(708) 327-3182