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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
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

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Agnes Hospital
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
Tri-County Hematology and Oncology Associates
Coordinator of this site? Confirm its status
CantonUnited StatesRecruiting
Cancer Care Specialists of Central Illinois
Coordinator of this site? Confirm its status
DecaturUnited StatesRecruiting
NY Cancer and Blood Specialists
Coordinator of this site? Confirm its status
East SetauketUnited StatesRecruiting
Truman Medical Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Sacred Heart Medical Oncology
Coordinator of this site? Confirm its status
PensacolaUnited StatesRecruiting
Oregon Oncology Specialists Salem
Coordinator of this site? Confirm its status
SalemUnited StatesRecruiting
Fred Hutchinson Cancer Research Center
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Avera Cancer
Coordinator of this site? Confirm its status
Sioux FallsUnited StatesRecruiting
Stamford Hospital
Coordinator of this site? Confirm its status
StamfordUnited StatesRecruiting
Stockton Hematology Oncology Medical Group Inc
Coordinator of this site? Confirm its status
StocktonUnited StatesRecruiting
SUNY Upstate Medical University
Coordinator of this site? Confirm its status
SyracuseUnited StatesRecruiting
Northwest Medical Specialties
Coordinator of this site? Confirm its status
TacomaUnited StatesRecruiting
MultiCare Health System Institute
Coordinator of this site? Confirm its status
TacomaUnited StatesRecruiting
Baylor Scott and White Research
Coordinator of this site? Confirm its status
TempleUnited StatesRecruiting
Lundquist Inst BioMed at Harbor
Coordinator of this site? Confirm its status
TorranceUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.