NCT07091019Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 14 Jul 2025
- Start date
- 17 Dec 2025
- Primary completion date
- 20 Apr 2033
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT07091019
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 17 Dec 2025 to the primary completion date, 20 Apr 2033
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently being treated with a CML TKI in 3L or beyond.
- Currently in TFR phase and are not on active CML TKI therapy.
- Previously received treatment with a prior stem cell transplant
Other illness
- Active participation in an interventional trial that may influence the management of their Ph+-CML-CP disease.
Other
- Known presence of T315I mutation.
- Pregnant or nursing (lactating) female.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Agnes Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Tri-County Hematology and Oncology Associates Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Cancer Care Specialists of Central Illinois Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| NY Cancer and Blood Specialists Coordinator of this site? Confirm its status | East Setauket | United States | Recruiting |
| Truman Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Sacred Heart Medical Oncology Coordinator of this site? Confirm its status | Pensacola | United States | Recruiting |
| Oregon Oncology Specialists Salem Coordinator of this site? Confirm its status | Salem | United States | Recruiting |
| Fred Hutchinson Cancer Research Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Avera Cancer Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Stamford Hospital Coordinator of this site? Confirm its status | Stamford | United States | Recruiting |
| Stockton Hematology Oncology Medical Group Inc Coordinator of this site? Confirm its status | Stockton | United States | Recruiting |
| SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| Northwest Medical Specialties Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
| MultiCare Health System Institute Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
| Baylor Scott and White Research Coordinator of this site? Confirm its status | Temple | United States | Recruiting |
| Lundquist Inst BioMed at Harbor Coordinator of this site? Confirm its status | Torrance | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.