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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Blood draws, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety, side effects, and best dose of asciminib to help keep leukemia from coming back. It is for adults with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), a blood cancer with a certain gene change, after a stem cell transplant or CAR T-cell therapy, which uses immune cells to fight cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, have confirmed Ph+ ALL, and give written consent to join.
  • At first screening, have a stem cell transplant or CAR T-cell treatment planned within 30 days, or have received it within the past 30 days.
  • For the later screening, be 30–150 days after treatment. Transplant cells must be making blood cells, or low blood counts after CAR T-cell therapy must have recovered.
  • The bone marrow test around day 30 must show fewer than 5% immature cancer cells, no cancer outside the marrow, and no need for blood transfusions. There must be no visible signs that leukemia has returned.
  • Be able to care for yourself and be out of bed for at least half the day. Blood counts must meet the study's limits.
  • Liver, kidney, heart, and oxygen tests must meet the study's limits.
  • Meet infection testing rules. If HIV or hepatitis B or C tests are positive, the amount of virus in the blood must be too low to detect.
  • If able to become pregnant, have a negative pregnancy test. People who could have a child must use effective birth control or avoid sex that could cause pregnancy during treatment and for at least 120 days after the last dose.

Who can't join

  • Asciminib treatment failed before, or you take certain medicines that affect how the body handles drugs and cannot switch at least one week before treatment.
  • Certain heart problems, including a recent heart attack or bypass surgery, serious rhythm problems, or certain personal or family histories of heart rhythm disorders.
  • Pancreatitis, or swelling of the pancreas, within the past year, or long-term pancreatitis.
  • After a donor stem cell transplant, severe active graft-versus-host disease, where donor cells attack your body, or use of medicines not allowed by the study to control it.
  • A serious illness that is not controlled, or an active infection that is not getting better with treatment.
  • Another active cancer, unless it would not affect the study's safety or how results are judged.
  • Pregnancy or breastfeeding.
  • Any other condition that the study doctor thinks makes joining unsafe, or difficulty following all study steps.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (1)

CA