Recruiting
Phase 1

Asciminib

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT07250087

Conditions

Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Asciminib

Study Details

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.

Conditions

Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Study ID

NCT07250087

Start date

Jan 21, 2026

Status verified date

Mar, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients post-alloHCT

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

experimental: Patients post-CAR T cell therapy

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

Interventions

Asciminib

Treatment will be administered on an outpatient basis.

Primary outcome measure

  • Recommended Phase 2 Dose [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Valerie Trujillo

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

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Rawan Faramand, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-03-27.