Asciminib as Maintenance Treatment for Philadelphia Chromosome Positive ALL
This study is testing asciminib as a maintenance treatment for adults with a specific type of leukemia called Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). You might be eligible if you have Ph+ ALL and have already received cellular therapies like a stem cell transplant or CAR T-cell therapy. The main goals are to see how safe asciminib is and to find the best dose to help prevent the cancer from coming back. Researchers will also look at how long people respond to the treatment and their overall survival. This study is for adults aged 18 and older who have been diagnosed with Ph+ ALL.
- Study design
- This is an interventional study with a planned enrollment of 30 participants. It aims to evaluate the safety and best dose of asciminib in two groups: those who had a stem cell transplant and those who had CAR T-cell therapy.
- What's involved
- You would take asciminib by mouth. You would also undergo blood sample collection, bone marrow aspirations, bone marrow biopsies, and echocardiography tests.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure adverse events from the start of treatment on day 1 to the end of cycle 1 on day 28. Other outcomes like duration of response and survival will be evaluated at 1 year post cellular therapy.
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NCT07040982
Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Recruiting
PHASE1Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~30 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:AsciminibBiospecimen CollectionBone Marrow AspirationBone Marrow BiopsyEchocardiography TestSurvey Administration
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over From start of treatment on day 1 to the end of cycle 1 on day 28
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Ibrahim Aldoss · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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)
What this trial measures
- Incidence of adverse eventsFrom start of treatment on day 1 to the end of cycle 1 on day 28
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.