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

RecruitingPhase 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Conditions: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Interventions: Asciminib

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Tampa, Florida, United States