Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT07040982 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-06-27
Summary
This phase I trial tests the safety, side effects and best dose of asciminib as maintenance treatment for adults with Philadelphia chromosome positive acute lymphoblastic leukemia (ALL) who have undergone cellular therapies such as hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor (CAR) T cell therapy. Maintenance treatment is given to help keep cancer from coming back after it has disappeared following initial therapy. Asciminib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving asciminib may be safe and tolerable as maintenance treatment for adult patients with Philadelphia chromosome positive ALL who have undergone cellular therapies.
Conditions
- B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Interventions
- DRUG
-
Asciminib
Given PO
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- PROCEDURE
-
Bone Marrow Aspiration
Undergo bone marrow aspiration
- PROCEDURE
-
Bone Marrow Biopsy
Undergo bone marrow biopsy
- PROCEDURE
-
Echocardiography Test
Undergo echocardiography
- OTHER
-
Survey Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Ibrahim Aldoss · City of Hope Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2028-06-13
- Completion
- 2028-06-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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