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Phase 1B CC-486 (ONUREG) in Combination Therapy in Acute Myeloid Leukemia(AML) - The OMNIVERSE Trial
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
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