Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL
About this study
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.
- Condition
- Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
- Tested
- Asciminib
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Study condition: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
- 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 5
- 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
Where
1 site, 1 recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Contact
-
Valerie Trujillo
813-745-3178 Valerie.Trujillo@moffitt.org
Potential match only. Final eligibility is determined by the study team.