Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL

Recruiting now · Phase 1

Conditions studied: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT07250087

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

36

Starts

2026-01-21

Expected to finish

2029-11-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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