Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
All eligible participants will receive oral CC-486 in combination with venetoclax.
Conditions
This trial is treating people with acute myeloid leukaemia
Eligibility
Inclusion
- 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
- 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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have been diagnosed with cancer, but have not received any treatment.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Celgene Corporation
Scientific 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)
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