RecruitingPhase 1

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

United States36 participantsStarted 2026-01-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Recommended Phase 2 Dose

Timeframe: Up to 24 months

Trial details

NCT IDNCT07250087

SponsorH. Lee Moffitt Cancer Center and Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-11

Contact for this trial

Valerie Trujillo

813-745-3178 Valerie.Trujillo@moffitt.org

View on ClinicalTrials.gov More Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia trials