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Could a gentle pill stop blood cancer before it starts?

NCT ID NCT07435636

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a low-dose oral drug (decitabine with tetrahydrouridine) in 80 adults aged 60–85 who have a high-risk blood condition called CCUS, which often leads to blood cancer. The drug aims to reduce harmful mutations in blood cells and restore normal blood production without the harsh side effects of standard cancer treatments. Participants will receive either the drug or a placebo for 24 weeks to see if it can safely prevent disease progression.

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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

60 to 85 years

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. Age ≥ 60 and ≤ 85 years old 2. Clonal Cytopenia of Uncertain Significance (CCUS), defined by all of the following: a. Persistent cytopenia, present on at least two occasions, at least four months apart, with no other cause identified: i. Hemoglobin (Hb) \< 120 g/L in people born female, and \< 130 g/L in people born male ii. Platelet count \< 150 x 109/L iii. Absolute Neutrophil Count (ANC) \< 1.8 x109/L b. Clonal hematopoiesis (CH) driver mutation confirmed by custom gene panel mutation analysis c. absence of features diagnostic for defined myeloid neoplasm (MN) on bone marrow examination 3. CH driver mutation variant allele fraction (VAF) of ≥ 10% 4. For participants living with HIV: 1. Receiving and adherent to suppressive antiretroviral therapy for at least 12 months 2. CD4+T cell count ≥ 0.35 x 109/L 3. HIV viral load \< 50 copies/mL 6\. Performance status by Eastern Cooperative Oncology Group (ECOG) Criteria of 0 or 1 7. For participants who are of childbearing potential, or whose partners are of childbearing potential: 1. Agreement to use at least two highly effective (per Clinical Trial Facilitation Group) contraceptive methods throughout the course of the trial, and for 6 months following the last dose of trial drug 2. Refrain from donating eggs or sperm during the same period 3. Confirmation of a negative serum pregnancy test at screening and at the beginning of each treatment cycle visit (for female participants of childbearing potential) 8. Provision of signed written informed consent document prior to any trial-related assessments or procedures being carried out Exclusion Criteria: 1. ANC \< 0.5 x109/L 2. Serum AST (Aspartate transaminase) or ALT (Alanine aminotransaminase) \> 3 times of upper limit of normal 3. Calculated or measured creatinine clearance ≤ 50 mL/min 4. Significant active cardiac disease within the previous 6 months, including: 1. New York Heart Association (NYHA) class III or IV congestive heart failure 2. Unstable angina or angina requiring surgical or medical intervention 3. Myocardial infarction 4. New or unstable cardiac arrhythmia. Stable or controlled arrhythmias are permitted 5. Active systemic infections: 1. Infection with ongoing signs/symptoms related to the infection without improvement despite appropriate anti-infectives 2. Active Hepatitis B infection (HBV) (defined as HBsAg positive, or HBcAb positive and measurable HBV DNA; participants who are HBcAb positive must have HBV DNA assayed during screening) 3. Active Hepatitis C Virus (HCV) will be ineligible if there is clinical hepatic dysfunction or other systemic manifestations of HCV disease, or if the hepatic eligibility parameters above are not met. Consideration should be given to curative HCV therapy prior to enrolment in consultation with HCV clinician 6. Any history of hematological or solid malignancy in previous the 5 years unless the participant has been free of disease for ≥ 36 months. However, participants with the following history/concurrent conditions are not excluded: 1. Basal or squamous cell carcinoma of the skin 2. Carcinoma in situ of the cervix 3. Carcinoma in situ of the breast 4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis \[TNM\] clinical staging system) 7. Known hypersensitivity to trial drugs or their constituents 8. Currently enrolled in the treatment phase of an interventional investigational trial. 9. Pregnant or breast-feeding individuals 10. Any condition not already outlined above which, in the opinion of the Principal Investigator, would place the participant at risk if they participated or would jeopardize adherence, follow up, or confound the ability to interpret trial data

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Canberra Health Services

    Canberra, Australian Capital Territory, 2605, Australia

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031, Australia

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.