Blood cancer drug safety checked in small Follow-Up study
NCT ID NCT02494258
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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5 people
The number who actually took part.
- Started
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Oct 2015
- Finished
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Apr 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Local Institution - 101
Gainesville, Florida, 32610-0277, United States
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Local Institution - 102
Houston, Texas, 77030, United States
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Local Institution - 103
Baltimore, Maryland, 21231, United States
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Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
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