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Could an arsenic drink replace IV drips for leukemia patients?

NCT ID NCT06882031

Disease control Sponsor: SDK Therapeutics, Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an oral liquid form of arsenic trioxide (SDK001) in 12 people with acute promyelocytic leukemia (APL). Researchers compared how well the body absorbs the oral drug versus the standard IV version, and whether food or calcium supplements change absorption. The goal was to gather early data on dosing and safety, not to treat the disease directly.

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 solution and intravenous)
What this could lead to
If successful, this could lead to a more convenient oral version of arsenic trioxide for APL patients, reducing the need for IV infusions.
What could go wrong
This is a very early Phase 1 study with only 12 people, focused on drug absorption, not on curing or controlling the disease. The oral version may not work as well as the IV form.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

12 people

The number who actually took part.

Started

Mar 2025

Finished

Jun 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: -Diagnosis of APL characterized by the presence of the t(15;17) translocation or promyelocytic leukemia/retinoic acid receptor alpha gene expression Exclusion Criteria: * Relapsed or refractory APL

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Conditions

The condition(s) this trial relates to.

acute promyelocytic leukemia

As listed by the trial registrant

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

Acute promyelocytic leukemia (APL)

Contacts and locations

Locations

  • The University of Hong Kong-Clinical Trial Centre Phase 1 Centre

    Hong Kong, Hong Kong

More trials for these conditions

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