RecruitingPhase 1NCT07250087

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


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

36 participants

Start Date

Jan 21, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called asciminib, taken after a stem cell transplant or CAR-T cell therapy, can prevent leukemia from coming back in adults with a type of leukemia called Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). Asciminib targets the abnormal BCR-ABL protein that drives this leukemia. **You may be eligible if...** - You are 18 or older - You have Ph+ALL (a type of leukemia with the Philadelphia chromosome) - You are currently in remission (fewer than 5% abnormal cells in bone marrow) after a stem cell transplant or CAR-T therapy - Your general health (ECOG 0–2) and organ function are adequate **You may NOT be eligible if...** - Your leukemia has come back (more than 5% abnormal cells) - You have moderate-to-severe graft-versus-host disease requiring systemic steroids - You have significant organ dysfunction or an uncontrolled infection - You are pregnant or breastfeeding - You previously received a different investigational CAR-T product Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAsciminib

Treatment will be administered on an outpatient basis.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT07250087


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