Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

NCT07040982 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 25023NCI-2025-04103P30CA033572
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial tests the safety, side effects and best dose of asciminib as maintenance treatment for adults with Philadelphia chromosome positive acute lymphoblastic leukemia (ALL) who have undergone cellular therapies such as hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor (CAR) T cell therapy. Maintenance treatment is given to help keep cancer from coming back after it has disappeared following initial therapy. Asciminib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving asciminib may be safe and tolerable as maintenance treatment for adult patients with Philadelphia chromosome positive ALL who have undergone cellular therapies.

Conditions

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The toxicity/adverse event information recorded on each subject will include type, severity, duration, attribution/ association with the study agent by arm and cycle. Tables will be constructed to summarize the observed incidence, severity and type of toxicity, including infection. Point estimates and 90% confidence intervals will be provided.

  From start of treatment on day 1 to the end of cycle 1 on day 28

Secondary Outcomes (12)

• Number of patients who have completed at least 3 cycles of asciminib and have taken ≥ 70% planned doses in each cycle post cellular therapy

  Up to completion of 3 cycles (cycle length= 28 days)

• Duration of remission

  Up to 1 year after completion of study treatment

• Relapse including minimal residual disease (MRD) relapsed

  Up to 1 year after completion of study treatment

• Relapse free survival

  From start of protocol therapy to relapse, or death, up to 1 year after completion of study treatment

• Overall survival

  From start of protocol therapy to death regardless of cause, up to 1 year after completion of study treatment

Study Arms (1)

Treatment (Asciminib)

EXPERIMENTAL

Patients receive asciminib PO QD or BID on days 1-28 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography during screening and as clinically indicated, and bone marrow biopsy, bone marrow aspirate and blood sample collection throughout the study.

Drug: Asciminib; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Echocardiography Test; Other: Survey Administration

Interventions

Asciminib DRUG

Given PO

Also known as: ABL 001, ABL-001, ABL001

Treatment (Asciminib)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (Asciminib)

Bone Marrow Aspiration PROCEDURE

Undergo bone marrow aspiration

Treatment (Asciminib)

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Treatment (Asciminib)

Echocardiography Test PROCEDURE

Undergo echocardiography

Also known as: EC, Echocardiography

Treatment (Asciminib)

Survey Administration OTHER

Ancillary studies

Treatment (Asciminib)

Eligibility Criteria

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

You may qualify if:

• PRE-SCREENING: Documented informed consent of the participant and/or legally authorized representative
• PRE-SCREENING: Age ≥ 18 years
• PRE-SCREENING: Participant was diagnosed with Ph+ ALL according to World Health Organization criteria. The BCR::ABL1 translocation may be detected by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), next generation sequencing (NGS), or cytogenetics at least once any time prior to cellular therapy. Participants may have p190 or p220 isoform, and participants with T315I mutation are not excluded
• PRE-SCREENING: Participant meets one of the following criteria:
• Arm 1: Have a date for HSCT scheduled within the next 30 days or have received HSCT within the last 30 days. Note: all HSCT donors, conditioning regimens, and GVHD prophylaxis regimens will be acceptable.
• Arm 2: Have a date for CAR T cell infusion scheduled within the next 30 days or have received CAR T cell infusion within the last 30 days
• PRE-SCREENING: History of pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
• PRE-SCREENING: History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
• PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Documented informed consent of the participant and/or legally authorized representative.
• Assent, when appropriate, will be obtained per institutional guidelines
• PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Eastern Cooperative Oncology Group (ECOG) ≤ 2
• PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Participant is between day +30 and +150 after one of the following cellular therapies:
• Arm 1: HSCT
• Participants on Arm 1 must be fully engrafted post-HSCT.
• Arm 2: CD19-targeted CAR T cell therapy (brexucabtagene autoleucel, tisagenlecleucel, obecabtagene autoleucel, investigational CD19 CAR T cell therapy)

You may not qualify if:

• Prior treatment failure with asciminib
• Treatment with strong inducers of CYP3A is not allowed and should be switched to an alternative at least 1 week prior to the start of study treatment
• ARM 1: Treatment with prior HSCT is allowed
• ARM 2: Treatment with prior CAR T cell therapy is allowed
• Cardiac or cardiac repolarization abnormality, including any of the following:
• History within 6 months prior to starting study treatment of myocardial infarction (MI), or coronary artery bypass graft (CABG)
• Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block)
• Fridericia's corrected QT interval (QTcF) at screening ≥ 450 msec (male patients), ≥ 470 msec (female patients)
• Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome
• History of pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
• ARM 1: Active grade 3 or higher graft-versus-host disease (GVHD) after allogeneic HSCT within 14 days of enrollment. Note: prednisone administration (flat dose of 0.5 mg/kg) is allowed. Patients receiving any other medication to control active/progressive GVHD will be excluded
• Clinically significant uncontrolled illness
• Active infection not responding to treatment
• Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Females only: Pregnant or breastfeeding

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical center

Duarte, California, 91010, United States

Location

MeSH Terms

Interventions

asciminib; Specimen Handling; Biopsy

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Ibrahim Aldoss

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 27, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 13, 2028
• Study Completion (Estimated): June 13, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

US (1)