Asciminib Maintenance Therapy Following alloHCT or CAR T... | NCT07250087

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

NCT07250087

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Status

Recruiting

Last Update Posted

Mar 27, 2026Actual

Enrollment

36Estimated

Phase

Phase 1

Conditions

Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Interventions

Asciminib

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jan 21, 2026Actual

Primary Completion Date

Nov 2029Estimated

Completion Date

Nov 2029Estimated

First Submitted Date

Nov 18, 2025

First Submission Date that Met QC Criteria

Nov 18, 2025

First Posted Date

Nov 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2026

Last Update Posted Date

Mar 27, 2026Actual

Name	Class
Novartis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Asciminib	Drug	Treatment will be administered on an outpatient basis.	Patients post-CAR T cell therapy Patients post-alloHCT

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Valerie Trujillo	Contact	813-745-3178		Valerie.Trujillo@moffitt.org

Overall Officials

Name	Affiliation	Role
Rawan Faramand, MD	Moffitt Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Moffitt Cancer Center	Recruiting	Tampa	Florida	33612	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000621806	asciminib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided