A Real-world Chronic Myelogenous Leukemia (CML) Patient Disease Registry to Describe Patient Experience and Clinical Outcomes Among Patients With CML Receiving Approved First or Second Line Tyrosine Kinase Inhibitor (TKI) Therapy
ASC4REAL-2
1 other identifier
observational
1,000
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2025
CompletedFirst Posted
Study publicly available on registry
July 29, 2025
CompletedStudy Start
First participant enrolled
December 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 20, 2033
July 20, 2026
July 1, 2026
7.3 years
July 14, 2025
July 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of discontinuation of index TKI due to AEs
Rate of discontinuation of index Tyrosine kinase inhibitor (TKI) due to Adverse Events (AEs)
Up to 5 years
Secondary Outcomes (13)
Overview of AEs
Up to 5 years
Rate and time to switches in TKI
Up to 5 years
Time to discontinuation of TKI, and reasons for TKI treatment discontinuatio
Up to 5 years
Distributions of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Up to 5 years
Functional Assessment of Chronic Illness Therapy - Item-GP5 (FACIT GP5)
Up to 5 years
- +8 more secondary outcomes
Study Arms (5)
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
There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
University of Alabama at Birmingham
Birmingham, Alabama, 35233-0271, United States
Stockton Hematology Oncology Medical Group Inc
Stockton, California, 95204, United States
Lundquist Inst BioMed at Harbor
Torrance, California, 90509-2910, United States
Stamford Hospital
Stamford, Connecticut, 06902, United States
Sacred Heart Medical Oncology
Pensacola, Florida, 32504, United States
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526, United States
St Agnes Hospital
Baltimore, Maryland, 21229, United States
Truman Medical Center
Kansas City, Missouri, 64108, United States
NY Cancer and Blood Specialists
East Setauket, New York, 11733, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Tri-County Hematology and Oncology Associates
Canton, Ohio, 44718, United States
Oregon Oncology Specialists Salem
Salem, Oregon, 97301, United States
Avera Cancer
Sioux Falls, South Dakota, 57105, United States
Baylor Scott and White Research
Temple, Texas, 76502, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
MultiCare Health System Institute
Tacoma, Washington, 98405, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Novartis Pharmaceuticals
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2025
First Posted
July 29, 2025
Study Start
December 17, 2025
Primary Completion (Estimated)
April 20, 2033
Study Completion (Estimated)
April 20, 2033
Last Updated
July 20, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share