Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Asciminib.
- Who it may be relevant to
- Registry conditions: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Asciminib
Treatment will be administered on an outpatient basis.
Primary outcome measures
- Recommended Phase 2 Dose [Time frame: Up to 24 months]
Secondary outcome measures (2)
- Relapse-free survival (RFS) [Time frame: Up to 24 Months]
- Overall survival (OS) [Time frame: Up to 24 Months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Moffitt Cancer Center — Tampa
Identifiers
NCT: NCT07250087 · MCC-23477