About this trial
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age <18 years
Weight ≥40kg
Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome
Alanine aminotransferase (ALT) ≤ 3 x ULN, OR
Disqualifiers
Active serious infection not controlled by oral or intravenous antibiotics.
Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.
Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.
Prolonged QTc interval on pre-entry electrocardiogram (> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist
Trial design
Single group
Treatments tested in this trial
Blinatumomab
DrugGiven by Infusion
Asciminib
DrugGiven by PO
Treatment groups
Trial outcomes
Primary outcomes
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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M.D. Anderson Cancer Center
Lead sponsor
Novartis Pharmaceuticals
Collaborator