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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
• Intervention / Treatment: Drug: Asciminib

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Valerie Trujillo; Phone Number: 813-745-3178; Email: Valerie.Trujillo@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Sub-Investigator: Melissa Alsina, MD
      • Sub-Investigator: Lia Perez, MD
      • Sub-Investigator: Doris Hansen, MD
      • Sub-Investigator: Hien Liu, MD
      • Sub-Investigator: Omar Castaneda Puglianini, MD
      • Sub-Investigator: Ciara Freeman, MD
      • Principal Investigator: Rawan Faramand, MD
      • Sub-Investigator: Michael Jain, MD
      • Sub-Investigator: Frederick Locke, MD
      • Sub-Investigator: Asmita Mishra, MD
      • Sub-Investigator: Taiga Nishihori, MD
      • Sub-Investigator: Nelli Bejanyan, MD
      • Sub-Investigator: Farhad Khimani, MD
      • Sub-Investigator: Sayeef Mirza, MD
      • Sub-Investigator: Bijal Shah, MD
      • Sub-Investigator: Aleksandr Lazaryan, MD
      • Sub-Investigator: Fabiana Perna, MD
      • Sub-Investigator: Joseph Pidala, MD
      • Sub-Investigator: Reshma Ramlal, MD
      • Sub-Investigator: Nancy Torres Luna, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients post-alloHCT; Individuals who have previously undergone an allogeneic stem cell transplant (alloHCT).	Drug: Asciminib; Treatment will be administered on an outpatient basis.
Experimental: Patients post-CAR T cell therapy; Individuals who have received chimeric antigen receptor T cell therapy (CAR T).	Drug: Asciminib; Treatment will be administered on an outpatient basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recommended Phase 2 Dose	The MTD is defined as the highest dose level at which one or none of six patients experience a DLT.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse-free survival (RFS)	Relapse-free survival (RFS) is defined as the time from starting asciminib to the date of relapse or death, whichever comes first.	Up to 24 Months
Overall survival (OS)	Overall survival (OS) is defined as the time from starting asciminib to the date of death.	Up to 24 Months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Novartis
• Investigators: Principal Investigator: Rawan Faramand, MD, Moffitt Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: asciminib
• Other Study ID Numbers: MCC-23477

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No