CML ADVOCATES NETWORK

Clinical Trials

ASC4REAL-2 (CABL001J1US01) = Patient Experience and Clinical Outcomes Among CML Patients Receiving TKI Therapy [USA]

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Study title

A Real-world Registry to Describe Patient Experience and Clinical Outcomes Among Patients Receiving TKI Therapy

Scientific title

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 (ASC4REAL-2)

Type of study

Observational (Patient Registry)

Phase

Observational (Patient Registry)

Current status

Recruiting

Other trial ID

ClinicalTrials.gov NCT07091019

What is the purpose of the study

This CML disease registry aims to gather evidence on the tolerability, safety, effectiveness, and patient-reported outcomes in real-world healthcare from patients with Philadelphia chromosome positive (Ph+) CML in chronic phase (CP) treated with TKIs approved for first line (1L) and second line (2L).

What will happen during the study

Patients will be enrolled and followed up for up to 5 years to assess patient experience and long-term clinical outcomes.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years and older at the time of Ph+-CML-CP diagnosis.
  • are receiving TKI treatment (asciminib, bosutinib, dasatinib, imatinib, or nilotinib) in routine medical care either as initial therapy or after 1 prior TKI therapy.
  • are receiving treatment at US and US territories (i.e., Puerto Rico) medical practice (e.g. community-based, office-based, hospital-based, academic).
  • are willing to provide written informed consent prior to study participation.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • are actively participating in any interventional trial that may influence the management of their Ph+-CML-CP disease.
  • are currently receiving a CML TKI in third line (3L) or beyond.
  • have a known T315I mutation.
  • are currently in treatment-free remission (TFR) phase and are not on active CML TKI therapy.
  • have received treatment with a prior stem cell transplant.
  • are pregnant or nursing (lactating) females.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

May 2033

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov, This is a database provided by the U. S. National Institutes of Health.

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Study Director: Novartis Pharmaceuticals

Principal investigator

Study Director: Novartis Pharmaceuticals

Study centers / principal investigators

United States

Alabama

University of Alabama at Birmingham
Birmingham, Alabama, 35233-0271
Principal Investigator: Omer Jamy

California

Stockton Hematology Oncology Medical Group Inc
Stockton, California, 95204
Principal Investigator: Ravleen Grewal

Lundquist Inst BioMed at Harbor
Torrance, California, 90509-2910
Principal Investigator: Sarah Elizabeth Tomassetti

Connecticut

Stamford Hospital
Stamford, Connecticut, 06902
Principal Investigator: Joshua Dower

Florida

Sacred Heart Medical Oncology
Pensacola, Florida, 32504
Principal Investigator: Dany El-Sayah

Illinois

Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526
Principal Investigator: James Wade

Maryland

St Agnes Hospital
Baltimore, Maryland, 21229
Principal Investigator: Carole Miller

Missouri

Truman Medical Center
Kansas City, Missouri, 64108
Principal Investigator: Anuj Shrestha

New York

NY Cancer and Blood Specialists
East Setauket, New York, 11733
Principal Investigator: Adam Hines

SUNY Upstate Medical University
Syracuse, New York, 13210
Principal Investigator: Gillian Kupakuwana-Suk

Ohio

Tri-County Hematology and Oncology Associates
Canton, Ohio, 44718
Principal Investigator: Norman Rafique

Oregon

Oregon Oncology Specialists Salem
Salem, Oregon, 97301
Principal Investigator: John Strother

South Dakota

Avera Cancer
Sioux Falls, South Dakota, 57105
Principal Investigator: Tiffani Kirkpatrick

Texas

Baylor Scott and White Research
Temple, Texas, 76502
Principal Investigator: Lucas Wong

Washington

Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Principal Investigator: Vivian Oehler

MultiCare Health System Institute
Tacoma, Washington, 98405
Principal Investigator: Nehal Masood

Northwest Medical Specialties
Tacoma, Washington, 98405
Principal Investigator: Ali Dadla