Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asciminib | Drug | Asciminib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients post-alloHCT
- description
- Individuals who have previously undergone an allogeneic stem cell transplant (alloHCT).
- interventionNames
- Drug: Asciminib
- type
- EXPERIMENTAL
- label
- Patients post-CAR T cell therapy
- description
- Individuals who have received chimeric antigen receptor T cell therapy (CAR T).
- interventionNames
- Drug: Asciminib
Primary outcomes (1)
- measure
- Recommended Phase 2 Dose
- timeFrame
- Up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available