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

Обзор

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.

Вмешательства

• Другое TKIs
  There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.

Первичные конечные точки

• Rate of discontinuation of index TKI due to AEs [Срок оценки: Up to 5 years]

Вторичные конечные точки (12)

• Overview of AEs [Срок оценки: Up to 5 years]
• Rate and time to switches in TKI [Срок оценки: Up to 5 years]
• Time to discontinuation of TKI, and reasons for TKI treatment discontinuatio [Срок оценки: Up to 5 years]
• Distributions of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Срок оценки: Up to 5 years]
• Functional Assessment of Chronic Illness Therapy - Item-GP5 (FACIT GP5) [Срок оценки: Up to 5 years]
• Distributions of the PRO instrument Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-GH-10) [Срок оценки: Up to 5 years]
• Distributions of the PRO instrument Medication Adherence Report Scale - 10 (MARS-10) [Срок оценки: Up to 5 years]
• Rates of molecular responses at/by specified timepoints [Срок оценки: Up to 5 years]
• Duration of molecular responses [Срок оценки: Up to 5 years]
• Rates of complete hematological response (CHR) at/by specified timepoints [Срок оценки: Up to 5 years]
• Failure-free survival (FFS) [Срок оценки: Up to 5 years]
• Progression-free survival (PFS) [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 17 центров

• University of Alabama at Birmingham — Birmingham
• Stockton Hematology Oncology Medical Group Inc — Stockton
• Lundquist Inst BioMed at Harbor — Torrance
• Stamford Hospital — Stamford
• Sacred Heart Medical Oncology — Pensacola
• Cancer Care Specialists of Central Illinois — Decatur
• St Agnes Hospital — Baltimore
• Truman Medical Center — Kansas City
• … и ещё 9 центров

Идентификаторы

NCT: NCT07091019 · CABL001J1US01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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