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NCT04887857 | COMPLETED | Leukemia, Myeloid, Acute

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

Celgene

Brief 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.

Condition or disease

Leukemia, Myeloid, Acute

Intervention/treatment

CC-486

Venetoclax

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 6 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2021-12-01
Estimated Primary Completion Date : 2024-01-08
Estimated Study Completion Date : 2024-01-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

Location Details

NCT04887857

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Local Institution - 104

Stanford, California, United States, 94305-5317

Not yet recruiting

United States, Colorado

Local Institution - 110

Denver, Colorado, United States, 80218

Not yet recruiting

United States, Massachusetts

Local Institution - 105

Boston, Massachusetts, United States, 02114

Not yet recruiting

United States, New York

Local Institution - 106

New York, New York, United States, 10029

Not yet recruiting

United States, New York

Local Institution - 113

New York, New York, United States, 10065

Not yet recruiting

United States, Ohio

Local Institution - 102

Cleveland, Ohio, United States, 44195

Not yet recruiting

United States, Oklahoma

Local Institution - 111

Oklahoma City, Oklahoma, United States, 73104

Not yet recruiting

United States, Texas

Local Institution - 101

Houston, Texas, United States, 77003

Not yet recruiting

Australia, Victoria

Local Institution - 202

North Melbourne, Victoria, Australia, 3002

Not yet recruiting

Australia,

Local Institution - 201

Melbourne, Australia, 3004