Recruiting

CML with TKIs

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07091019

Conditions

Chronic Myelogenous Leukemia - Chronic Phase

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

TKIs

Study Details

Brief summary:

This CML disease registry (ASC4REAL-2) aims to gather evidence on the tolerability, safety, effectiveness, and patient-reported outcomes (PRO) in real-world healthcare from patients with Ph+-CML-CP treated with TKIs approved for 1L and 2L, including prospective follow-up for 5 years identifying and describing long-term treatment outcomes.

Conditions

Chronic Myelogenous Leukemia - Chronic Phase

Study ID

NCT07091019

Start date

Dec 17, 2025

Status verified date

Jul, 2026

Completion date

Apr 20, 2033

Anticipated

Primary completion date

Apr 20, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Asciminib

Patients who started their 1L or 2L asciminib following FDA approval on or after Oct-2024 OR Patients who have exited an asciminib interventional study in US for 1L/2L CML and are continuing treatment with asciminib in routine medical care

Bosutinib

Patients who started 1L or 2L bosutinib on or after Oct-2021

Dasatinib

Patients who started 1L or 2L dasatinib on or after Oct-2021

Imatinib

Patients who started 1L or 2L imatinib on or after Oct-2021

Nilotinib

Patients who started 1L or 2L nilotinib on or after Oct-2021

Interventions

TKIs

There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.

Primary outcome measure

  • Rate of discontinuation of index TKI due to AEs [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233-0271

Contacts

+1 205 502 9967

Principal Investigator:

Omer Jamy

Stockton Hematology Oncology Medical Group Inc

Recruiting

Stockton, California, United States, 95204

Contacts

+1 209 466 2626

Principal Investigator:

Ravleen Grewal

Lundquist Inst BioMed at Harbor

Recruiting

Torrance, California, United States, 90509-2910

Principal Investigator:

Sarah Elizabeth Tomassetti

Stamford Hospital

Recruiting

Stamford, Connecticut, United States, 06902

Principal Investigator:

Joshua Dower

Sacred Heart Medical Oncology

Recruiting

Pensacola, Florida, United States, 32504

Contacts

+1 850 416 2730

Principal Investigator:

Dany El-Sayah

Cancer Care Specialists of Central Illinois

Recruiting

Decatur, Illinois, United States, 62526

Principal Investigator:

James Wade

St Agnes Hospital

Recruiting

Baltimore, Maryland, United States, 21229

Contacts

+1 410 368 3412

Principal Investigator:

Carole Miller

Truman Medical Center

Recruiting

Kansas City, Missouri, United States, 64108

Principal Investigator:

Anuj Shrestha

NY Cancer and Blood Specialists

Recruiting

East Setauket, New York, United States, 11733

Principal Investigator:

Adam Hines

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Principal Investigator:

Gillian Kupakuwana-Suk

Tri-County Hematology and Oncology Associates

Recruiting

Canton, Ohio, United States, 44718

Principal Investigator:

Norman Rafique

Oregon Oncology Specialists Salem

Recruiting

Salem, Oregon, United States, 97301

Principal Investigator:

John Strother

Avera Cancer

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

+1 605 322 3064

Principal Investigator:

Tiffani Kirkpatrick

Baylor Scott and White Research

Recruiting

Temple, Texas, United States, 76502

Contacts

+1 254 935 5838

Principal Investigator:

Lucas Wong

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109-1024

Contacts

+1 206 667 7315

Principal Investigator:

Vivian Oehler

MultiCare Health System Institute

Recruiting

Tacoma, Washington, United States, 98405

Contacts

+1 253 403 5265

Principal Investigator:

Nehal Masood

Northwest Medical Specialties

Recruiting

Tacoma, Washington, United States, 98405

Contacts

+1 253 428 8756

Principal Investigator:

Ali Dadla

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • CML,
  • CMP-CP,
  • ASC4REAL,
  • ASC4REAL-2,
  • chronic phase,
  • BCR-ABL, MMR,
  • TKI,
  • Tyrosine Kinase Inhibitor,
  • molecular response,
  • adult,
  • registry,
  • PRO,
  • patient reported outcome,
  • QOL,
  • quality of life,
  • asciminib,
  • bosutinib,
  • imatinib,
  • nilotinib,
  • dasatinib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-20.