Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL
NCT ID: NCT07250087
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
36 participants
INTERVENTIONAL
2026-01-31
2029-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients post-alloHCT
Individuals who have previously undergone an allogeneic stem cell transplant (alloHCT).
Asciminib
Treatment will be administered on an outpatient basis.
Patients post-CAR T cell therapy
Individuals who have received chimeric antigen receptor T cell therapy (CAR T).
Asciminib
Treatment will be administered on an outpatient basis.
Interventions
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Asciminib
Treatment will be administered on an outpatient basis.
Eligibility Criteria
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Inclusion Criteria
* 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
* Grade II-IV acute GVHD requiring systemic steroids
* Significant organ dysfunction or uncontrolled infection
* Pregnancy or breastfeeding
* Prior investigational CAR T product
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Rawan Faramand, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Countries
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Central Contacts
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Other Identifiers
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MCC-23477
Identifier Type: -
Identifier Source: org_study_id