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

Phase 1RecruitingNCT07250087

H. Lee Moffitt Cancer Center and Research Institute36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Recommended Phase 2 Dose

The MTD is defined as the highest dose level at which one or none of six patients experience a DLT.

Time frame: Up to 24 months

Secondary Outcomes

Relapse-free survival (RFS)

Relapse-free survival (RFS) is defined as the time from starting asciminib to the date of relapse or death, whichever comes first.

Time frame: Up to 24 Months

Overall survival (OS)

Overall survival (OS) is defined as the time from starting asciminib to the date of death.