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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows adults with chronic myelogenous leukemia (CML), a blood cancer, in its chronic phase and with a gene change called the Philadelphia chromosome. It tracks approved TKI medicines, which block signals that help cancer cells grow, used as the first or second treatment. Over 5 years, it will track safety, side effects, how well treatment works, and patients' experiences in everyday care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Were at least 18 when diagnosed with Philadelphia chromosome-positive CML in the chronic phase.
  • Take asciminib, bosutinib, dasatinib, imatinib, or nilotinib in regular care, as your first TKI medicine or after one other TKI.
  • Get care at a medical practice in the United States or a US territory, such as Puerto Rico.
  • Sign a consent form before joining and agree to let researchers use a code to link and access your health records or insurance claims without your name.

Who can't join

  • Are in a study testing a treatment that may affect your CML care.
  • Are taking your third or later TKI treatment for CML.
  • Have a known gene change called T315I.
  • Are in treatment-free remission, meaning your CML is under control without active TKI treatment.
  • Have had a stem cell transplant.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (17)

AL

CA

CT

FL

IL

  • Cancer Care Specialists of Central Illinois · Decatur, IL 62526James Wade · Principal investigatorMore trials in Decatur

MD

MO

NY

OH

  • Tri-County Hematology and Oncology Associates · Canton, OH 44718Norman Rafique · Principal investigatorMore trials in Canton

OR

  • Oregon Oncology Specialists Salem · Salem, OR 97301John Strother · Principal investigatorMore trials in Salem

SD

TX

WA