A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

Completed · Phase 1

Conditions studied: Leukemia, Myeloid, Acute

In brief

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.

Key facts

Study ID

NCT04887857

Run by

Celgene

People needed

6

Starts

2021-12-01

Expected to finish

2024-01-08

Last updated by the study team

2024-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 104 — Stanford, California, United States
• Local Institution - 110 — Denver, Colorado, United States
• Local Institution - 105 — Boston, Massachusetts, United States
• Local Institution - 106 — New York, New York, United States
• Local Institution - 113 — New York, New York, United States
• Local Institution - 102 — Cleveland, Ohio, United States
• Local Institution - 111 — Oklahoma City, Oklahoma, United States
• Local Institution - 101 — Houston, Texas, United States
• Local Institution - 202 — North Melbourne, Victoria, Australia
• Local Institution - 201 — Melbourne, Australia

Full record on ClinicalTrials.gov

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