Clinical trial · Observational
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
NCT07091019CI-TRIAL-00118556ASC4REAL-2recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia - Chronic Phase | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TKIs | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Asciminib
- description
- 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
- interventionNames
- Other: TKIs
- label
- Bosutinib
- description
- Patients who started 1L or 2L bosutinib on or after Oct-2021
- interventionNames
- Other: TKIs
- label
- Dasatinib
- description
- Patients who started 1L or 2L dasatinib on or after Oct-2021
- interventionNames
- Other: TKIs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.