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

NCT07091019 | Not Yet Recruiting

• 1 other identifier: CABL001J1US01
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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

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

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

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

Other: TKIs

Bosutinib

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

Other: TKIs

Dasatinib

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

Other: TKIs

Imatinib

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

Other: TKIs

Nilotinib

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

Other: TKIs

Interventions

TKIs OTHER

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

Also known as: Scemblix, Bosulif, Sprycel, Gleevec, Tasigna

Asciminib; Bosutinib; Dasatinib; Imatinib; Nilotinib

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

asciminib; bosutinib; Dasatinib; Imatinib Mesylate; nilotinib

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

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: November 15, 2025
• Primary Completion (Estimated): May 15, 2033
• Study Completion (Estimated): May 15, 2033
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share