Education and Training

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

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.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • drug: CC-486
  • drug: Venetoclax

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tian Yi Zhang
+1 650-498-6000
Not Recruiting