CML ADVOCATES NETWORK

Clinical Trials

Decitabine, Lisaftoclax, and Olverembatinib in Advanced CML and Philadelphia Chromosome-Positive AML [USA]

Study title

Decitabine, Lisaftoclax, and Olverembatinib in Advanced CML and Philadelphia Chromosome-Positive AML

Scientific title

A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia

Type of study

Trial after therapy failure or intolerance, treatment of advanced phases

Phase

1

Current status

Recruiting

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Other trial ID

ClinicalTrials.gov NCT06401603; 2024-0032

What is the purpose of the study

This is a trial to find the recommended doses of lisaftoclax and olverembatinib that can be given in combination with decitabine to participants with advanced CML and Ph+ AML.

What will happen during the study

All patients will be given decitabine as intravenous infusion, lisaftoclax by mouth (orally), and olverembatinib by mouth. The dose of lisaftoclax given will depend on when particants join the study.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged at least 18 years
  • have been diagnosed with chronic myelogenous leukemia in accelerated phase (CML-AP), chronic myelogenous leukemia in myeloid blast phase (CML-MBP), or Philadelphia chromosome-positive acute myeloid leukemia by WHO 2016 criteria
  • are intolerant or resistant to at least one prior BCR::ABL1 tyrosine kinase inhibitor (TKI) treatment
  • have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2

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

Key exclusion criteria

This study does not include patients who:

  • have previously received lisaftoclax or olverembatinib
  • have a history of acute pancreatitis within 1 year of study or history of chronic pancreatitis
  • have active grade III-V cardiac failure as defined by the New York Heart Association Criteria
  • clinically significant and uncontrolled cardiovascular disease, as defined in the study protocol

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

Estimated primary completion date

January 2027

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 Ascentage Pharma Group Inc.

Scientific lead / contact

Principal investigator

Nicholas Short, MD
MD Anderson Cancer Center
Houston, Texas, 77030

Study centers / principal investigators

United States

MD Anderson Cancer Center
Houston, Texas, 77030
Principal investigator: Nicholas Short, MD