Asciminib after transplant or CAR T therapy in Philadelphia chromosome-positive acute lymphoblastic leukemia
Tests asciminib's safety after transplant or CAR T in adults with Ph+ acute lymphoblastic leukemia.
Key facts
- Who runs it
- H. Lee Moffitt Cancer Center and Research Institute
- Where
- Tampa, United StatesSee the site
- Trial code
- Registry title
- Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 36 people, planned
- Started
- 21 Jan 2026
- Expected to end
- Nov 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- Asciminib
- Record updated
- 27 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) in remission after a donor stem cell transplant or CAR T-cell therapy. It tests asciminib as maintenance treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Ph+ B-ALL with detectable Philadelphia chromosome abnormalities, in remission (less than 5% blasts in the bone marrow).
- Earlier treatment
- Must have had an allogeneic stem cell transplant (cohort A) or CAR T-cell therapy (cohort B). Cannot have had a prior investigational CAR T product.
- Biomarker or test result
- Detectable Philadelphia chromosome abnormalities.
Main reasons for not taking part
- Active relapsed disease (more than 5% blasts)
- Grade II-IV acute graft-versus-host disease needing systemic steroids
- Significant organ problems or uncontrolled infection
- Pregnancy or breastfeeding
- Prior investigational CAR T product
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Grade II-IV acute GVHD requiring systemic steroids
- Prior investigational CAR T product
- Active relapsed disease (>5% blasts)
- Significant organ dysfunction or uncontrolled infection
- Pregnancy or breastfeeding
Where in United States
- Moffitt Cancer CenterTampa, United StatesContact: Rawan Faramand, MD (principal investigator)Taking people
About the trial
What the trial wants to find out
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
Read full original descriptionShow less
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.
The 2 groups in the trial
- Patients post-alloHCTTreatment being tested
Individuals who have previously undergone an allogeneic stem cell transplant (alloHCT).
Treatment: Asciminib
- Patients post-CAR T cell therapyTreatment being tested
Individuals who have received chimeric antigen receptor T cell therapy (CAR T).
Treatment: Asciminib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Asciminib after transplant or CAR T therapy in Philadelphia chromosome-positive acute lymphoblastic leukemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 27 March 2026