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

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Enrolling; Phase 1

Conditions: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Treatments: Drug: Asciminib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07250087

MCC-23477

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Patients post-alloHCT

Experimental group

Description:

Individuals who have previously undergone an allogeneic stem cell transplant (alloHCT).

Treatment:

Drug: Asciminib

Patients post-CAR T cell therapy

Experimental group

Description:

Individuals who have received chimeric antigen receptor T cell therapy (CAR T).

Treatment:

Drug: Asciminib