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Massive CML registry launches to reveal how TKIs really perform

NCT ID NCT07091019

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Updated 2 times

Summary

This registry will follow 1,000 adults with chronic-phase CML who are taking approved TKIs (like Gleevec or Tasigna) as their first or second treatment. Over 5 years, researchers will track side effects, treatment changes, and patient-reported experiences to understand how these drugs work in real-world settings, not just in clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tyrosine kinase inhibitors (TKIs) such as asciminib, bosutinib, dasatinib, imatinib, nilotinib
What this could lead to
If successful, this registry could provide clearer insights into how well different TKIs work and are tolerated in everyday medical practice, helping doctors and patients make more informed treatment decisions.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by differences in patient care and reporting.

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 1,000 people

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

Started

Dec 2025

Expected to finish

Apr 2033

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 with Ph+-CML-CP who, at enrollment, are receiving 1 of 5 TKI treatments included in this registry either as initial therapy or after 1 prior TKI therapy.

Ages

18 to 100 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: * 18 years or older at the time of Ph+-CML-CP diagnosis. * Receiving TKI treatment (asciminib, bosutinib, dasatinib, imatinib, or nilotinib) in routine medical care either as initial therapy or after 1 prior TKI therapy. * Receiving treatment at US and US territories (i.e., Puerto Rico) medical practice (e.g. community-based, office-based, hospital-based, academic). * Signed informed consent form (ICF) prior to participation in the study including agreement to be tokenized so that the patient's anonymized RWD (EMRs and/or claims data) can be accessed. Exclusion Criteria: * Active participation in an interventional trial that may influence the management of their Ph+-CML-CP disease. * Currently being treated with a CML TKI in 3L or beyond. * Known presence of T315I mutation. * Currently in TFR phase and are not on active CML TKI therapy. * Previously received treatment with a prior stem cell transplant * Pregnant or nursing (lactating) female.

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myeloid, Chronic-Phase

As listed by the trial registrant

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

Chronic myelogenous leukemia - 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

    17 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

  • Avera Cancer

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Baylor Scott and White Research

    RECRUITING

    Temple, Texas, 76502, United States

  • Cancer Care Specialists of Central Illinois

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109-1024, United States

  • Lundquist Inst BioMed at Harbor

    RECRUITING

    Torrance, California, 90509-2910, United States

  • MultiCare Health System Institute

    RECRUITING

    Tacoma, Washington, 98405, United States

  • NY Cancer and Blood Specialists

    RECRUITING

    East Setauket, New York, 11733, United States

  • Northwest Medical Specialties

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Oregon Oncology Specialists Salem

    RECRUITING

    Salem, Oregon, 97301, United States

  • SUNY Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • Sacred Heart Medical Oncology

    RECRUITING

    Pensacola, Florida, 32504, United States

  • St Agnes Hospital

    RECRUITING

    Baltimore, Maryland, 21229, United States

  • Stamford Hospital

    RECRUITING

    Stamford, Connecticut, 06902, United States

  • Stockton Hematology Oncology Medical Group Inc

    RECRUITING

    Stockton, California, 95204, United States

  • Tri-County Hematology and Oncology Associates

    RECRUITING

    Canton, Ohio, 44718, United States

  • Truman Medical Center

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233-0271, United States

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