A Phase II Trial of Asciminib, Dasatinib, Prednisone, and Blinatumomab for Participants with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia

 

Anjali S. Advani, MD
&
Michaela Liedtke, MD

21CTP.LEUK01 Study Chairs


ACTIVATED:  5/15/2025

For sites that are members of the SWOG Cancer Research Network ONLY:
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21CTP.LEUK01 Study Synopsis

Schema

 

21CTP.Leuk01 schema

Objective
  • To assess the rate of major molecular remission (MMR) by polymerase chain (PCR) for BCR-ABL at day 85 in newly diagnosed participants with Philadelphia-chromosome positive Ph+ acute lymphoblastic leukemia (ALL) treated with asciminib, dasatinib, and prednisone.
Key Eligibility

Inclusion Criteria

  1. Newly diagnosed Ph+ ALL patients, 18 or older, with presence of the BCR-ABL fusion detected by cytogenetics, FISH or PCR
  2. Zubrod performance status 0-3
  3. Calculated creatinine clearance ≥ 50mL/min using the Cockcroft-Gault Formula within 14 days prior to registration
  4. AST and ALT ≤ 3 x IULN within 14 days prior to registration
  5. Bilirubin ≤ 2 x IULN within 14 days prior to registration
  6. Ejection fraction ≥ 50% based on echocardiogram of MUGA
  7. QTcF < 500 ms (by Fridericia calculation) based on EKG performed within 28 days prior to registration

Exclusion Criteria

  1. No history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, active ALL in the CNS confirmed by CSF analysis, or other significant CNS abnormalities.
  2. Patients must not have received any prior chemotherapy, investigational agents, radiation therapy, or other therapy for the treatment of ALL other than the following for a maximum of 7 days: FDA-approved TKI therapy, steroids, hydroxyurea, leukapheresis, and intrathecal chemotherapy.
  3. Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/ symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment).
  4. Patients must not have clinically significant autoimmune disease.
  5. Patients with known history of (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration.
  6. Patients must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
  7. Patients must discontinue proton pump inhibitors at the initiation of treatment.
  8. Patients must not have a history of or current acute pancreatitis, chronic pancreatitis, or any ongoing pancreatic disease.


    Specimen Collection

    Specimen submission summary table

     

     

    Study Contact Information

    Funding Questions:
    [email protected]

    Protocol Questions Contact:
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    View Trial Page at clinicaltrials.gov