©2024 Stanford Medicine
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
Not Recruiting
Trial ID: NCT04887857
Purpose
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy
of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute
Myeloid Leukemia (AML) and newly diagnosed AML.
Official Title
A Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG®) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)
Stanford Investigator(s)
Tian Yi Zhang, MD, PhD. https://www.thezhanglabstanford.com/
Assistant Professor of Medicine (Hematology)
Eligibility
Inclusion Criteria:
- Confirmation of the following for Acute Myeloid Leukemia (AML)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. ECOG 3 is
allowed if participants are 18 to 74 years old with comorbidities
- Agree to serial bone marrow aspirate/biopsies
Exclusion Criteria:
- Suspected or proven to have acute promyelocytic leukemia based on morphology,
immunophenotype, molecular assay, or karyotype
- Received prior hypomethylating agent (HMA) therapy for myelodysplastic
syndromes/Chronic myelomonocytic leukemia then develop AML within 4 months of
discontinuing the HMA therapy
- Prior history of malignancy unless the participant has been free of the disease for ≥
1 year prior to the start of study treatment
Other protocol-defined inclusion/exclusion criteria apply
Intervention(s):
drug: CC-486
drug: Venetoclax
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Tian Yi Zhang
+1 650-498-6000