NCT07250087PHASE1Recruiting
Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL
H. Lee Moffitt Cancer Center and Research Institute
Start Date
1/21/2026
Completion Date
11/1/2029
Summary
The purpose of the study is to see if a study drug called asciminib is safe and okay for people to take after they've had treatment for a type of blood cancer called Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ B-ALL). We're looking at two groups of adults: one group had an Allogeneic Stem Cell Transplant (alloHCT) cohort A, and the other group had chimeric antigen receptor T cell (CAR T) therapy, cohort B. We also want to figure out what the best dose of asciminib is to use moving forward in future studies.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Age ≥18 years
* Diagnosis of Ph+ B-ALL with detectable Philadelphia chromosome abnormalities
* Morphologic remission (\<5% marrow blasts)
* ECOG performance status 0-2
* Adequate organ function
Exclusion Criteria:
* Active relapsed disease (\>5% blasts)
* Grade II-IV acute GVHD requiring systemic steroids
* Significant organ dysfunction or uncontrolled infection
* Pregnancy or breastfeeding
* Prior investigational CAR T product
Interventions
DRUG
Asciminib
Conditions
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Locations
Moffitt Cancer Center
Tampa, Florida 33612
United States