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New leukemia drug asciminib tracked in real-world saudi study

NCT ID NCT06684964

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study follows about 40 adults in Saudi Arabia with chronic-phase chronic myeloid leukemia (CML) who have already tried two other targeted therapies. Researchers will track how well asciminib controls the cancer, its side effects, and how consistently patients take the medication. The goal is to see how the drug performs in everyday medical practice, not in a controlled lab setting.

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.

Participants

About 40 people

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

Started

Mar 2025

Expected to finish

Dec 2026

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.

Who is studied

Patients must have been prescribed asciminib for a maximum of 6 months before enrolling in the study. Patients will be included in the study regardless of their MMR status at the initiation of asciminib treatment.

Ages

18 to 99 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: Patients eligible for inclusion in this study must meet all the following criteria: 1. Signed and dated Patient Informed Consent Form obtained. 2. Male or female patients with a diagnosis of Ph+ CML-CP ≥18 years of age with the following laboratory values: 1. \<15% blasts in peripheral blood and bone marrow 2. \<30% blasts plus promyelocytes in peripheral blood and bone marrow 3. \<20% basophils in the peripheral blood 4. ≥50 x 109/L (≥50,000/mm3) platelets 4\. Prior treatment with a minimum of 2 prior TKIs: e. First-generation TKI imatinib f. 2G-TKI dasatinib, nilotinib and bosutinib g. 3G-TKI ponatinib 4. Patients are currently receiving asciminib as per approved local label and independently of study participation. Patients must have started asciminib therapy no more than 6 months prior to their enrollment in the study. Exclusion Criteria: Patients meeting ANY of the following criteria are not eligible for participation: 1. Asciminib based treatment regimen in first or second line. 2. Patients are currently participating in any other clinical trials. 3. Patients who refused to sign informed consent. 4. According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reasons such as unavailability or severe concomitant illnesses.

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive

As listed by the trial registrant

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

Chronic myelogenous leukemia in chronic phase

How to take part

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

  1. The places running it

    4 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

  • Novartis Investigative Site

    RECRUITING

    Dammam, 15215, Saudi Arabia

  • Novartis Investigative Site

    RECRUITING

    Jeddah, 21423, Saudi Arabia

  • Novartis Investigative Site

    RECRUITING

    Riyadh, 11211, Saudi Arabia

  • Novartis Investigative Site

    RECRUITING

    Riyadh, 11426, Saudi Arabia