Skip to main content
OpenTrials
Completed

NCT Number: NCT04887857

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Leukemia, Myeloid, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 202, North Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CC-486

Drug

Specified dose on specified days

Other names: ONUREG®, oral azacitidine

Venetoclax

Drug

Specified dose on specified days

Other names: VENCLEXTA®, VENCLYXTO®

Primary outcomes

  1. Maximum Tolerated Dose (MTD)

    Time frame: Up to 42 days after first dose

  2. Incidence of type of adverse events (AEs)

    Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug

  3. Incidence of frequency of AEs

    Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug

  4. Incidence of severity of AEs

    Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug

  5. Incidence of relationship of AEs to study treatment

    Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug

  6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug

  7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

    Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug

  8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug

Secondary outcomes

  1. Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)

    Time frame: Up to approximately 12 months

  2. Overall Response Rate (ORR)

    Time frame: Up to approximately 12 months

  3. Minimal Residual Disease (MRD) Response Rate

    Time frame: Up to approximately 12 months

  4. MRD Conversion Rate

    Time frame: Up to approximately 12 months

  5. Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)

    Time frame: Up to approximately 12 months

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Collaborators

  • AbbVie

Registry information

Official study 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)

Acronym: OMNIVERSE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 14, 2021
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.