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Recruiting NCT07091019

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

— Observational Chronic Myelogenous Leukemia - Chronic Phase

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TKIs.
Who it may be relevant to
Registry conditions: Chronic Myelogenous Leukemia - Chronic Phase. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Rate of discontinuation of index TKI due to AEs [Time frame: Up to 5 years]
Secondary outcome measures (12)
  • Overview of AEs [Time frame: Up to 5 years]
  • Rate and time to switches in TKI [Time frame: Up to 5 years]
  • Time to discontinuation of TKI, and reasons for TKI treatment discontinuatio [Time frame: Up to 5 years]
  • Distributions of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Time frame: Up to 5 years]
  • Functional Assessment of Chronic Illness Therapy - Item-GP5 (FACIT GP5) [Time frame: Up to 5 years]
  • Distributions of the PRO instrument Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-GH-10) [Time frame: Up to 5 years]
  • Distributions of the PRO instrument Medication Adherence Report Scale - 10 (MARS-10) [Time frame: Up to 5 years]
  • Rates of molecular responses at/by specified timepoints [Time frame: Up to 5 years]
  • Duration of molecular responses [Time frame: Up to 5 years]
  • Rates of complete hematological response (CHR) at/by specified timepoints [Time frame: Up to 5 years]
  • Failure-free survival (FFS) [Time frame: Up to 5 years]
  • Progression-free survival (PFS) [Time frame: Up to 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 17 centers
  • 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
  • … and 9 more centers

Identifiers

NCT: NCT07091019 · CABL001J1US01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗