Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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 criteria
Qualifiers
Age ≥18 years
Diagnosis of Ph+ B-ALL with detectable Philadelphia chromosome abnormalities
Morphologic remission (<5% marrow blasts)
ECOG performance status 0-2
Disqualifiers
Active relapsed disease (>5% blasts)
Grade II-IV acute GVHD requiring systemic steroids
Significant organ dysfunction or uncontrolled infection
Pregnancy or breastfeeding
Trial design
Treatments tested in this trial
- Asciminib
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Novartis
Collaborator
Source ClinicalTrials.gov