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Recruiting

NCT Number: NCT07250087

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

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.

Recruiting

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Key information

Conditions

Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Aleksandr Lazaryan, MD

SUB_INVESTIGATOR

Asmita Mishra, MD

SUB_INVESTIGATOR

Bijal Shah, MD

SUB_INVESTIGATOR

Ciara Freeman, MD

SUB_INVESTIGATOR

Doris Hansen, MD

SUB_INVESTIGATOR

Fabiana Perna, MD

SUB_INVESTIGATOR

Farhad Khimani, MD

SUB_INVESTIGATOR

Frederick Locke, MD

SUB_INVESTIGATOR

Hien Liu, MD

SUB_INVESTIGATOR

Joseph Pidala, MD

SUB_INVESTIGATOR

Lia Perez, MD

SUB_INVESTIGATOR

Melissa Alsina, MD

SUB_INVESTIGATOR

Michael Jain, MD

SUB_INVESTIGATOR

Nancy Torres Luna, MD

SUB_INVESTIGATOR

Nelli Bejanyan, MD

SUB_INVESTIGATOR

Omar Castaneda Puglianini, MD

SUB_INVESTIGATOR

Rawan Faramand, MD

PRINCIPAL_INVESTIGATOR

Reshma Ramlal, MD

SUB_INVESTIGATOR

Sayeef Mirza, MD

SUB_INVESTIGATOR

Taiga Nishihori, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Asciminib

Drug

Treatment will be administered on an outpatient basis.

Primary outcomes

  1. Recommended Phase 2 Dose

    Time frame: Up to 24 months

    The MTD is defined as the highest dose level at which one or none of six patients experience a DLT.

Secondary outcomes

  1. Relapse-free survival (RFS)

    Time frame: Up to 24 Months

    Relapse-free survival (RFS) is defined as the time from starting asciminib to the date of relapse or death, whichever comes first.

  2. Overall survival (OS)

    Time frame: Up to 24 Months

    Overall survival (OS) is defined as the time from starting asciminib to the date of death.

Study contacts

Contact information is provided by the study sponsor or research team.

Valerie Trujillo

CONTACT

[email protected]

813-745-3178

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Nov 26, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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