What this study is
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.
What's being tested
- TKIs
Intervention · OTHER
There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.
Study details
- Sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Myelogenous Leukemia - Chronic Phase
- Enrolling
- 1,000 people
- Starts
- 2025-12-17
- Est. completion
- 2033-04-20
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (17)
17 openUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
- Contact+1 205 502 9967
- Omer Jamy · Principal investigator
RecruitingStockton Hematology Oncology Medical Group Inc
Stockton, California, United States
- Contact+1 209 466 2626
- Ravleen Grewal · Principal investigator
RecruitingLundquist Inst BioMed at Harbor
Torrance, California, United States
- Sarah Elizabeth Tomassetti · Principal investigator
RecruitingStamford Hospital
Stamford, Connecticut, United States
- Joshua Dower · Principal investigator
RecruitingSacred Heart Medical Oncology
Pensacola, Florida, United States
- Contact+1 850 416 2730
- Dany El-Sayah · Principal investigator
RecruitingCancer Care Specialists of Central Illinois
Decatur, Illinois, United States
- James Wade · Principal investigator
RecruitingSt Agnes Hospital
Baltimore, Maryland, United States
- Contact+1 410 368 3412
- Carole Miller · Principal investigator
RecruitingTruman Medical Center
Kansas City, Missouri, United States
- Anuj Shrestha · Principal investigator
RecruitingNY Cancer and Blood Specialists
East Setauket, New York, United States
- Adam Hines · Principal investigator
RecruitingSUNY Upstate Medical University
Syracuse, New York, United States
- Gillian Kupakuwana-Suk · Principal investigator
RecruitingTri-County Hematology and Oncology Associates
Canton, Ohio, United States
- Norman Rafique · Principal investigator
RecruitingOregon Oncology Specialists Salem
Salem, Oregon, United States
- John Strother · Principal investigator
RecruitingAvera Cancer
Sioux Falls, South Dakota, United States
- Contact+1 605 322 3064
- Tiffani Kirkpatrick · Principal investigator
RecruitingBaylor Scott and White Research
Temple, Texas, United States
- Contact+1 254 935 5838
- Lucas Wong · Principal investigator
RecruitingFred Hutchinson Cancer Research Center
Seattle, Washington, United States
- Contact+1 206 667 7315
- Vivian Oehler · Principal investigator
RecruitingMultiCare Health System Institute
Tacoma, Washington, United States
- Contact+1 253 403 5265
- Nehal Masood · Principal investigator
RecruitingNorthwest Medical Specialties
Tacoma, Washington, United States
- Contact+1 253 428 8756
- Ali Dadla · Principal investigator
Recruiting
Study team
Sponsor
Novartis Pharmaceuticals
Study ID CABL001J1US01
Study director
Novartis Pharmaceuticals
Novartis Pharmaceuticals
CONTACT
Novartis Pharmaceuticals
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.