Could a pill replace IV drips for leukemia patients?
NCT ID NCT07296445
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial is testing whether an oral (pill) form of arsenic trioxide works as well as the standard IV form for consolidation therapy in people with a low-risk type of acute promyelocytic leukemia (APL). About 120 adults and teens who have already completed initial treatment will be randomly assigned to receive either the oral or IV version, plus another drug called ATRA. The goal is to see if the oral form is absorbed similarly, keeps cancer in remission, and improves quality of life by reducing hospital visits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- arsenic trioxide (oral or intravenous) plus all-trans retinoic acid (ATRA)
- What this could lead to
- If it works, this could make treatment for APL much easier by replacing frequent IV infusions with a pill, reducing hospital visits and improving quality of life.
- What could go wrong
- This is still a phase 3 trial, so it's not yet proven that the oral form works as well as the IV form. There may be differences in absorption or side effects, and the study is relatively small (120 people).
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- 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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12 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.
Show the full entry requirements Hide 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.
Key Inclusion Criteria: * Participants must have diagnosis of newly diagnosed non-high risk APL with a WBC count at diagnosis ≤ 10,000 cells/µL, completed induction with ATO/ATRA and achieved morphologic CR with hematologic recovery * Eastern Cooperative Oncology Group performance status ≤2 * Adequate liver, kidney, and cardiac function * Have a life expectancy of at least 9 months * Negative serum pregnancy test Key Exclusion Criteria: * Diagnosis of relapsed or refractory APL. * Fridericia's corrected QT interval (QTcF) \>450 milliseconds (males) and \>460 milliseconds (females) * Any gastrointestinal (GI) issue likely to affect oral drug absorption/metabolism or inability to swallow oral medication * Prior malignancy or currently receiving treatment for a non-APL malignancy, with the following exceptions: basal cell or squamous cell skin cancer treated with surgical resection, in situ cervical cancer, localized prostate cancer or breast cancer treated with hormone therapy or surgical resection, or other cancer from which the participant has been disease free for at least 2 years. * Pregnant or nursing females or is of reproductive potential and unwilling to comply with contraceptive requirements. * Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load. Note: Additional inclusion/exclusion criteria may apply, per protocol.
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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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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