Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL
Phase 1 Study of Asciminib Maintenance Therapy Following Allogeneic Stem Cell Transplant or Chimeric Antigen Receptor T Cell Therapy (CAR T) to Prevent Relapse in Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
H. Lee Moffitt Cancer Center and Research Institute
36 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria5
- 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
Treatment will be administered on an outpatient basis.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07250087