Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (NCT07040982) is a Phase 1 interventional studying B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, sponsored by City of Hope Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - PRE-SCREENING: Documented willing to sign a consent form 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 willing to sign a consent form 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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) * Participants on Arm 2 must be fully recovered from cytopenia * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Day 30 (+/- 5 days) marrow post cellular therapy should show evidence of complete morphologic remission defined as \< 5% bone marrow (BM) blasts, no extramedullary disease, and transfusion independence * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Participant should have no morphological evidence of relapse * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Absolute neutrophil count (ANC) ≥ 500/mm\^3 for 3 days * NOTE: Patients are allowed growth factors * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Platelets ≥ 75,000/mm\^3 * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Hemoglobin ≥ 9g/dL * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Aspartate aminotransferase (AST) ≤ 3.0 x ULN * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Alanine aminotransferase (ALT) ≤ 3.0 x ULN * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: serum creatinine \<1.5 mg/dL * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Left ventricular ejection fraction (LVEF) ≥ 50% * Note: To be performed within 28 days prior to day 1 of protocol therapy * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Bazett's corrected QT interval (QTcB) ≤ 480 ms * Note: To be performed within 28 days prior to day 1 of protocol therapy * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Oxygen (O2) saturation \> 90% on room air * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Seronegative for HIV antigen (Ag)/antibody (Ab) combination (combo), hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Meets other institutional and federal requirements for infectious disease titer requirements * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Agreement by females and males of childbearing potential\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 120 days after the last dose of protocol therapy. * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * 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 * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Treatments Being Tested

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

City of Hope Medical center

Duarte, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07040982), the sponsor (City of Hope Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07040982 clinical trial studying?

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 ma… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07040982?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07040982?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07040982. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07040982. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.