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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests asciminib in adults with Ph+ B-ALL, a blood cancer linked to a change in a chromosome. It is for people who have had a stem cell transplant from a donor or CAR T therapy, which uses immune cells to fight cancer. The study checks safety and finds the best dose for future studies, with the goal of keeping the cancer from coming back.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older.
- Have Ph+ B-ALL with a Philadelphia chromosome change found on testing.
- Cancer is in remission, with fewer than 5% immature cancer cells in the bone marrow.
- Can care for yourself and are up and about at least half of your waking hours.
- Organs are working well enough.
Who can't join
- Cancer has come back, with more than 5% immature cancer cells.
- Have grade II–IV acute graft-versus-host disease, where donor cells attack your body, and need steroids that treat the whole body.
- Have serious organ problems or an infection that is not controlled.
- Are pregnant or breastfeeding.
- Previously received an experimental CAR T treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
FL
- Moffitt Cancer Center · Tampa, FL 33612Rawan Faramand, MD · Principal investigatorMelissa Alsina, MD · Sub-investigatorNelli Bejanyan, MD · Sub-investigatorOmar Castaneda Puglianini, MD · Sub-investigatorMore trials in Tampa