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

Phase 1 Study of Asciminib Maintenance Therapy Following Allogeneic Stem Cell Transplant or Chimeric Antigen Receptor T Cell Therapy (CAR T) to Prevent Relapse in Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07250087

Enrollment

Registered

2025-11-26

Start date

2026-01-21

Completion date

2029-11-01

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Brief 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.

Interventions

DRUGAsciminib

Treatment will be administered on an outpatient basis.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Recommended Phase 2 Dose	Up to 24 months	The MTD is defined as the highest dose level at which one or none of six patients experience a DLT.

Secondary

Measure	Time frame	Description
Relapse-free survival (RFS)	Up to 24 Months	Relapse-free survival (RFS) is defined as the time from starting asciminib to the date of relapse or death, whichever comes first.
Overall survival (OS)	Up to 24 Months	Overall survival (OS) is defined as the time from starting asciminib to the date of death.

Countries

United States

Contacts

CONTACTValerie Trujillo

Valerie.Trujillo@moffitt.org813-745-3178

PRINCIPAL_INVESTIGATORRawan Faramand, MD

Moffitt Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026