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New pill could transform leukemia treatment, phase 3 trial begins

NCT ID NCT07504458

Disease control Sponsor: Quetzal Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Updated 15 times

Summary

This study tests a new oral drug, QTX-2101, combined with standard ATRA therapy for adults newly diagnosed with a low-risk form of acute promyelocytic leukemia (APL). The goal is to see if the oral capsule works as well as the current intravenous treatment. About 150 participants will be enrolled to measure how many achieve complete molecular remission and to check safety.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

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

Started

Jun 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

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 to 71 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. Informed Consent 2. Participants must be between 18 and under 71 years of age 3. Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA) 4. Participants must be classified as low- or intermediate-risk APL 5. Participants must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraception guidance, and other procedures Exclusion Criteria 1. Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG 2. Participants who have central nervous system leukemia 3. Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make study participation unsafe 4. Participants who are pregnant, breastfeeding, or unwilling to use contraception 5. Participants who are unable to safely take study medication, including severe neuropathy, inability to swallow oral medication, malabsorption issues, or known allergy to ATO or ATRA

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Conditions

The condition(s) this trial relates to.

acute promyelocytic leukemia hematologic disorder hematopoietic and lymphoid system neoplasm leukemia neoplasm

As listed by the trial registrant

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

Acute promyelocytic leukaemia Acute promyelocytic leukemia Acute promyelocytic leukemia (APL) Acute promyelocytic leukemia with PML-rara Acute promyelocytic leukemia with T(15;17)(Q24.1;Q21.2); PML-rara

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    23 sites in 4 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Quetzal Site 1

    RECRUITING

    Duarte, California, 91010, United States

    Contact Email: •••••@•••••

  • Quetzal Site 10

    RECRUITING

    Cáceres, 10003, Spain

    Contact Email: •••••@•••••

  • Quetzal Site 11

    RECRUITING

    Palma de Mallorca, Balearic Islands, 07120, Spain

    Contact Email: •••••@•••••

  • Quetzal Site 12

    RECRUITING

    Nashville, Tennessee, 37203, United States

    Contact Email: •••••@•••••

  • Quetzal Site 13

    RECRUITING

    Augusta, Georgia, 30912, United States

    Contact Email: •••••@•••••

  • Quetzal Site 14

    RECRUITING

    Paris, 75010, France

    Contact Email: •••••@•••••

  • Quetzal Site 15

    RECRUITING

    Barcelona, 08041, Spain

    Contact Email: •••••@•••••

  • Quetzal Site 16

    RECRUITING

    Birmingham, Alabama, 35233, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Quetzal Site 17

    RECRUITING

    Bordeaux, 33000, France

    Contact Email: •••••@•••••

  • Quetzal Site 18

    RECRUITING

    Lexington, Kentucky, 40536, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Quetzal Site 19

    RECRUITING

    Cluj-Napoca, 400015, Romania

    Contact Email: •••••@•••••

  • Quetzal Site 2

    RECRUITING

    The Bronx, New York, 10467, United States

    Contact Email: •••••@•••••

  • Quetzal Site 20

    RECRUITING

    Oviedo, 33011, Spain

    Contact Email: •••••@•••••

  • Quetzal Site 21

    RECRUITING

    Badalona, 08916, Spain

    Contact Email: •••••@•••••

  • Quetzal Site 22

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Quetzal Site 23

    RECRUITING

    Baltimore, Maryland, 21201, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Quetzal Site 3

    RECRUITING

    Charlottesville, Virginia, 22908, United States

    Contact Email: •••••@•••••

  • Quetzal Site 4

    RECRUITING

    Buffalo, New York, 14203, United States

    Contact Email: •••••@•••••

  • Quetzal Site 5

    RECRUITING

    Stanford, California, 94305, United States

    Contact Email: •••••@•••••

  • Quetzal Site 6

    RECRUITING

    Houston, Texas, 77030, United States

    Contact Email: •••••@•••••

  • Quetzal Site 7

    RECRUITING

    Los Angeles, California, 90033, United States

    Contact Email: •••••@•••••

  • Quetzal Site 8

    RECRUITING

    Columbus, Ohio, 43210, United States

    Contact Email: •••••@•••••

  • Quetzal Site 9

    RECRUITING

    Valencia, 46026, Spain

    Contact Email: •••••@•••••

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