Asciminib After Transplant or CAR T for Ph+ ALL

This study is looking at whether a drug called asciminib is safe and effective for adults with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ B-ALL) to take after they've had either an allogeneic stem cell transplant (alloHCT) or CAR T-cell therapy. The main goal is to find the best dose of asciminib to use in future studies. You might be able to join if you are at least 18 years old, have Ph+ B-ALL in remission (meaning less than 5% cancer cells in your bone marrow), and meet other health requirements. The study plans to include 36 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. The study aims to determine the recommended Phase 2 dose of asciminib.
What's involved
Treatment with asciminib will be given on an outpatient basis. The primary endpoint, which is about the recommended dose, will be measured for up to 24 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint will be measured for up to 24 months after treatment.

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NCT07250087

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~36 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:Asciminib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Phase 2 Dose
Measured over Up to 24 months
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
1 sites across 1 states
Florida1
  • Rawan Faramand, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

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Eligibility criteria

Inclusion

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

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
  • Recommended Phase 2 DoseUp to 24 months

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