Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT07250087
Phase
PHASE1
Status
Recruiting
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Conditions

  • Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Asciminib — DRUG
    Treatment will be administered on an outpatient basis.

Study Details

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.

Key Dates

Start date
Jan 21, 2026
Status verified
Mar 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Recommended Phase 2 Dose [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Rawan Faramand, MD (PRINCIPAL_INVESTIGATOR)
Melissa Alsina, MD (SUB_INVESTIGATOR)
Nelli Bejanyan, MD (SUB_INVESTIGATOR)
Omar Castaneda Puglianini, MD (SUB_INVESTIGATOR)
Ciara Freeman, MD (SUB_INVESTIGATOR)
Doris Hansen, MD (SUB_INVESTIGATOR)
Michael Jain, MD (SUB_INVESTIGATOR)
Farhad Khimani, MD (SUB_INVESTIGATOR)
Aleksandr Lazaryan, MD (SUB_INVESTIGATOR)
Hien Liu, MD (SUB_INVESTIGATOR)
Frederick Locke, MD (SUB_INVESTIGATOR)
Asmita Mishra, MD (SUB_INVESTIGATOR)
Taiga Nishihori, MD (SUB_INVESTIGATOR)
Lia Perez, MD (SUB_INVESTIGATOR)
Sayeef Mirza, MD (SUB_INVESTIGATOR)
Fabiana Perna, MD (SUB_INVESTIGATOR)
Joseph Pidala, MD (SUB_INVESTIGATOR)
Reshma Ramlal, MD (SUB_INVESTIGATOR)
Nancy Torres Luna, MD (SUB_INVESTIGATOR)
Bijal Shah, MD (SUB_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FL

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