Asciminib + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML [USA]

What is the purpose of the study

This is a study to evaluate asciminib (ABL001) taken in combination with dasatinib and prednisone (a steroid) as a possible treatment for B-cell Acute Lymphoblastic Leukemia (ALL) that is BCR-ABL positive (BCR-ABL+ B-ALL) or Chronic Myeloid Leukemia (CML) in lymphoid blast crisis. BCR-ABL+ B-ALL is also called Philadelphia chromosome positive Acute Lymphoblastic Leukemia (Ph+ ALL).

The  study assesses the safety and also tries to find the recommended dose of the investigational drug to use for further studies.

What will happen during the study

All patients will be given asciminib, dasatinib and prednisone orally (by mouth), and blinatumomab by intravenous infusion. The dose of asciminib 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 cytopathologically confirmed CD19+ BCR-ABL1+ acute leukemia (B-cell ALL, mixed phenotype acute leukemia, or CML in lymphoid blast crisis with ≥ 5% lymphoblasts)

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

Key exclusion criteria

This study does not include patients who:

• For dose escalation only: Participants suitable for and willing to receive standard intensive induction chemotherapy
• have a known ABL T315I mutation
• have received other chemotherapy, including antibody-based therapy, within 2 weeks of starting the study therapy with the exception of steroids, hydroxyurea, ATRA, and/or intrathecal chemotherapy
• have a history of prior or concurrent malignancy requiring current treatment and/or whose natural history has the potential to interfere with the safety or efficacy assessment of the treatment regimen that is being studied
• have acute or chronic liver disease.

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

Estimated primary completion date

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 centers / principal investigators

United States

Illinois

University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Contact: Wendy Stock, MD

Massachusetts

Dana Faber Cancer Institute
Boston, Massachusetts, 02115
Contact/Principal Investigator: Marlise Luskin, MD

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Contact: Jessica Liegel, MD

New York

Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Contact: Eunice Wang, MD