A Study to Evaluate Long-term Safety of CC-486 (Oral Azacitidine) in Subjects With Hematological Disorders

March 16, 2026 updated by: Celgene

A Phase 2, Open-Label, Single-Arm Rollover Study to Evaluate Long-Term Safety in Subjects Who Participated in Other Celgene Sponsored CC-486 (Oral Azacitidine) Clinical Trials in Hematological Disorders

Rollover study supporting hematological disorder indications from Celgene sponsored CC-486 (oral azacitidine) protocols eligible for participation in the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The open-label, multicenter, multinational rollover study is intended to evaluate the safety of CC-486 (oral azacitidine), while providing continued treatment with CC-486 for subjects who are receiving single agent CC-486 at the time of transition to the rollover study and tolerated the protocol prescribed regimen in Celgene-sponsored trials, and whom in the opinion of the Investigator may derive clinical benefit from continuing treatment with CC-486. Subjects' survival will also be followed if required by the parent CC-486 study protocol. If approved by Celgene, subjects from any ongoing or future Celgene sponsored CC-486 studies in hematological disorders will be included in this protocol.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
  • United States
    • Florida
      • Gainesville, Florida, United States, 32610-0277
        • Local Institution - 101
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Local Institution - 103
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution - 102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Previously participated in, and received oral azacitidine, and continues to fulfill the eligibility criteria in one of the parent oral azacitidine clinical trials.

    The Investigator believes the subject is tolerating treatment with oral azacitidine monotherapy and continued oral azacitidine treatment is of benefit to the subject.

  2. Understand and voluntarily sign an informed consent document prior to any study related assessments or procedures being conducted.
  3. Willing and able to adhere to the study visit schedule and other protocol requirements.

  4. Females of childbearing potential (FCBP) may participate, provided that the participant meets the following conditions:

    1. Have two negative pregnancy tests as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
    2. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with highly effective contraception without interruption, during screening, during the study treatment (including dose interruptions), and for 6 months after discontinuation of study treatment, or longer if required for each compound and/or by local regulations.

Subjects must satisfy the following criteria to participate in the Survival Follow-up phase:

  1. In order to be enrolled for the survival follow-up in the Follow-up Phase of the rollover study, subjects must have been in a parent oral azacitidine study where monitoring for survival was required and have signed informed consent for follow-up phase.
  2. Understand and voluntarily sign an informed consent document for this study.
  3. Willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

The presence of any of the following will exclude a subject from receiving investigational product in the study:

  1. Concomitant use of drugs that are prohibited.
  2. Prior chemotherapy (including injectable azacitidine) or radiotherapy or any investigational agent after the last dose of oral azacitidine administered as part of the parent oral azacitidine study.
  3. Subjects have met one or more criteria for discontinuation as stipulated in the parent oral azacitidine study.
  4. Subjects received oral azacitidine in combination with another compound during a parent oral azacitidine study (Subjects form multi-arm parent oral azacitidine studies will be allowed to enroll into the rollover study, if the subject is receiving single-agent oral azacitidine at the time of transition into the rollover study).
  5. A subject's transition into rollover study ≥ 45 days after End of the Study visit of the parent oral azacitidine study
  6. Pregnant or lactating females.

There are no exclusion criteria to prevent entry or remaining on the follow-up phase of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Azacitidine (CC-486)
This study is an open-label, single-arm study and is divided into the screening period, treatment period and follow-up period. It is intended to evaluate the long-term safety of CC-486 and is to be taken at the same dose, schedule and frequency used from the last dose of CC-486 given in the parent study.
Drug: CC-486
The subject will continue at the same dose, frequency and schedule used for the last dose of CC-486 given in the preceding CC-486 study. Subjects are allowed to rollover after the last cycle is finished and before the new cycle begins in the parent protocol. There is a 7 day window from End of Study on the parent protocol and when the participant will start Day 1 of the rollover study.
Other Names:
  • Onureg
  • Oral Azacitidine
  • BMS-986345

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events
Time Frame: From informed consent signed (Day 1) and until 28 days after the last dose of CC-486, or until the treatment discontinuation visit, whichever was later (up to approximately 90 months)
A treatment emergent adverse event is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.
From informed consent signed (Day 1) and until 28 days after the last dose of CC-486, or until the treatment discontinuation visit, whichever was later (up to approximately 90 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Who Survived
Time Frame: From informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
From informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2015

Primary Completion (Actual)

April 14, 2025

Study Completion (Actual)

April 14, 2025

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimated)

July 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-486-GEN-001
  • 2023-503272-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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