NCT07040982

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

Pilot Study of Asciminib as a Maintenance Treatment Post Cellular Therapies in Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the safety of asciminib maintenance in adults with Philadelphia chromosome (Ph)+ acute lymphoblastic leukemia (ALL) in morphological complete remission (CR) post hematopoietic stem cell transplantation (HSCT; Arm 1) or chimeric antigen receptor (CAR) T cell therapy (Arm 2). II. Determine the recommended phase 2 dosing (RP2D) of asciminib maintenance post cellular therapies in Ph+ ALL in each arm. SECONDARY OBJECTIVES: I. Evaluate feasibility of asciminib maintenance measured as the number of patients who continue asciminib \> 3 cycles post cellular therapy. II. Duration of response. III. Timing for minimal residual disease (MRD) and full relapse. IV. Relapse free survival at 1 year post cellular therapy. V. Overall survival at 1 year post cellular therapy. VI. Non-relapse mortality at 1 year post cellular therapy. VII. Relapse at 1 year post cellular therapy. VIII. Rates of asciminib discontinuation and interruption due to toxicity at 1 year post cellular therapy. IX. Rate of switching to another tyrosine kinase inhibitor (TKI) at 1 year post cellular therapy X. Rate and grade of acute graft-versus-host disease (GVHD) at 180 days post initiation of asciminib maintenance post HSCT. (Arm 1) XI. Rate and grade of chronic GVHD at 1 year post initiation of asciminib maintenance post HSCT. (Arm 1) XII. GVHD-free, relapse-free survival (GRFS) at 1 year post HSCT. (Arm 1) EXPLORATORY OBJECTIVES: I. For patients who are MRD-negative, evaluate MRD relapse by clonoSEQ during therapy. II. Evaluate immune cell populations and immune reconstitution post-transplant during asciminib therapy. III. Evaluate the impact of prevalent BCR-ABL mutations and treatment emergent BCR-ABL mutations. IV. Evaluate B-cell aplasia and CAR T cell persistence during asciminib therapy. (Arm 2) V. Quality of life assessments using Patient Reported Outcomes Measurement Information System (PROMIS). OUTLINE: This is a dose-escalation study of asciminib followed by a dose-expansion study. Patients receive asciminib orally (PO) once daily (QD) or twice daily (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. After completion of study treatment, patients are followed up at 30 days then every 3 months for 1 year.

Conditions

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

Interventions

Type	Name	Description
DRUG	Asciminib	Given PO
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow aspiration
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow biopsy
PROCEDURE	Echocardiography Test	Undergo echocardiography
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-06-13
• Completion: 2028-06-13
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study