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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Contact Information
Primary
Valerie Trujillo
Valerie.Trujillo@moffitt.org
813-745-3178
Time Frame
Start Date: 2026-01
Estimated Completion Date: 2029-11
Participants
Target number of participants: 36
Treatments
Experimental: Patients post-alloHCT
Individuals who have previously undergone an allogeneic stem cell transplant (alloHCT).
Experimental: Patients post-CAR T cell therapy
Individuals who have received chimeric antigen receptor T cell therapy (CAR T).
Related Therapeutic Areas
Sponsors
Leads: H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Novartis