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Blood cancer drug safety checked in small Follow-Up study

NCT ID NCT02494258

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of an oral chemotherapy drug (azacitidine) in 5 adults with blood cancers who had already taken it in earlier studies. Researchers tracked side effects and survival to see if continued treatment was safe. The goal was to monitor risks, not to test if the drug works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

5 people

The number who actually took part.

Started

Oct 2015

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Local Institution - 101

    Gainesville, Florida, 32610-0277, United States

  • Local Institution - 102

    Houston, Texas, 77030, United States

  • Local Institution - 103

    Baltimore, Maryland, 21231, United States

  • Manchester Royal Infirmary

    Manchester, M13 9WL, United Kingdom

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