[WIRB- IAA] Phase 1b/2 Study of AZD5153 Combined with Venetoclax in Relapsed/Refractory (Phase 1b) and Previously Untreated AML Patients (Phase 2)
The purpose of this study is to determine the safety and acceptability of the experimental drug, AZD5153 combined with Venetoclax.
Acute Myeloid Leukemia (AML)
-Participating in the Beat AML umbrella study master protocol (reference IRB# 16475)
-Diagnosed with AML
-Phase 1b: Age 18 years or older AND Relapsed/Refractory disease
-Phase 2: Age 60 or older AND NPM1 mutated/FLT3 wild type disease or marker negative disease as defined by IRB#16475 master protocol
18 - n/a
Healthy Volunteers Needed
Duration of Participation
Patients will receive up to 12 cycles of combination therapy with AZD5153 and venetoclax. After 12 cycles of combination therapy, AZD5153 will be continued until one of the following criteria occurs:
• Treatment failure, including rapidly progressive disease or severe organ dysfunction, not correctable by hydroxyurea cytoreduction during cycle 0, cycles 1 and 2.
• Disease progression after a response
• Withdrawal of consent
• Allogeneic hematopoietic stem cell transplantation or other cellular therapy
• An AE or intercurrent illness that precludes further administration of protocol therapy or
participation in the study
• The trial is discontinued due to safety issues or at the request of the Food and Drug Administration (FDA)
• Completion of 36 months of therapy
Patients will be followed for at least 30 days past the last administration of study drug. All patients will be followed for survival every 3 months after the 30-day follow-up visit until death. Patients who discontinue treatment for unacceptable AEs will be followed until resolution or stabilization of the AE, then for response and survival according to the schedule in the study
calendar. Patients in CRMRD-/CR/CRh will be followed for relapse of AML until death according to the schedule in the study calendar. If patients are unable to visit the site, the follow-up visit can be conducted by phone or electronic contact with the patient or authorized representative. This is only relevant for the survival follow up.
Clinical Trials Information Line
Beat AML, LLC, a division of the Leukemia and Lymphoma Society, Inc
Supported by: AstraZeneca