CML ADVOCATES NETWORK

Clinical Trials

Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia [USA]

Study title

Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia

Scientific title

Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia

Type of study

Trial after therapy failure or intolerance

Phase

2

Current status

Recruiting

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Other trial ID

2024-0396; NCI-2024-07923; ClinicalTrials.gov NCT06629584

What is the purpose of the study

The purpose of this study is to investigate asciminib in patients with chronic myeloid leukemia (CML) previously treated with one line of tyrosine kinase inhibitor (TKI) therapy.

What will happen during the study

All patients will receive asciminib (80 mg) as tablets once daily continuously for 28-day cycles for 2 years.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged at least 18 years at the time of screening
  • have been diagnosed with Philadelphia Chromosome-positive (Ph+) or BCR-ABL-positive CML in chronic phase (CML-CP) and have received one prior line of therapy with a TKI
  • have a history of treatment failure as defined in the study protocol
  • have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
  • have adequate kidney and liver function.

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

Key exclusion criteria

This study does not include patients who:

  • have a history of T315I mutation
  • have abnormalities of the heart as defined in the study protocol
  • have a known active infection with human immunodeficiency virus (HIV) or Hepatitis B or C.
  • have known conditions that would significantly affect the ingestion or gastrointestinal absorption of drugs administered orally
  • have a history of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.

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

Estimated primary completion date

December 2026

Where can I find additional information

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

Study sponsor

M.D. Anderson Cancer Center in collaboration with Novartis

Scientific lead / contact

Principal investigator

Ghayas Issa, MD
The University of Texas MD Anderson Cancer Center

Study centers / principal investigators

United States

Texas

The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Principal Investigtor: Ghayas Issa, MD