Acute Myeloid Leukemia Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

66

Study ID:

NCT04887857

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 10 Locations for this study

See Locations Near You

Stanford University
Stanford California, 94305, United States
Stanford University
Stanford California, 94305, United States More Info
Tian Zhang, Site 104
Contact
650-498-6000
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Massachusetts General Hospital / Dana-Farber Cancer Institute
Boston Massachusetts, 02114, United States
Massachusetts General Hospital / Dana-Farber Cancer Institute
Boston Massachusetts, 02114, United States More Info
Amir Fathi, Site 105
Contact
617-724-1124
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Icahn School Of Medicine At Mount Sinai
New York New York, 10029, United States More Info
Lewis Silverman, Site 106
Contact
212-241-6500
Cornell University Weill Medical College
New York New York, 10065, United States
Cornell University Weill Medical College
New York New York, 10065, United States More Info
Gail Roboz, Site 113
Contact
646-962-2700
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Hetty Carraway, Site 102
Contact
216-445-5899
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
MD Anderson Cancer Center
Houston Texas, 77003, United States
Local Institution - 202
North Melbourne Victoria, 3002, Australia More Info
Site 202
Contact
Alfred Hospital
Melbourne , 3004, Australia
Local Institution - 201
Melbourne , 3004, Australia More Info
Site 201
Contact

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

66

Study ID:

NCT04887857

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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