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

NCT07250087 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MCC-23477
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Relapse-free survival (RFS)

  Up to 24 Months

• Overall survival (OS)

  Up to 24 Months

Study Arms (2)

Patients post-alloHCT

EXPERIMENTAL

Individuals who have previously undergone an allogeneic stem cell transplant (alloHCT).

Drug: Asciminib

Patients post-CAR T cell therapy

EXPERIMENTAL

Individuals who have received chimeric antigen receptor T cell therapy (CAR T).

Drug: Asciminib

Interventions

Asciminib DRUG

Treatment will be administered on an outpatient basis.

Patients post-CAR T cell therapy; Patients post-alloHCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Novartis: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Interventions

asciminib

Study Officials

• Rawan Faramand, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Trujillo

CONTACT

813-745-3178; Valerie.Trujillo@moffitt.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: January 21, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)