AzTrials
AzTrials

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1Phase 1NCT07914166

Asciminib-Based Induction Therapy for the Treatment of Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

A Phase 1 study testing Asciminib, Biospecimen Collection and Blinatumomab in people with B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, run by City of Hope Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This phase I trial studies the side effects and best dose of asciminib when given together with intrathecal (IT) chemotherapy, dexamethasone, vincristine, and blinatumomab (asciminib-based induction therapy) in treating patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Asciminib, Biospecimen Collection and Blinatumomab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
13 Oct 2027to 13 Oct 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented informed consent of the participant and/or legally authorized representative
  • Newly diagnosed Ph+ or BCR-ABL1-positive ALL, as defined by the 2025 National Comprehensive Cancer Network (NCCN) guidelines
  • Age: ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease)
  • Aspartate aminotransferase (AST) ≤ 3.0 x ULN
Show all 20Show fewer
  • Alanine aminotransferase (ALT) ≤ 3.0 x ULN
  • Serum creatinine < 1.5 mg/dL
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • Note: To be performed within 28 days prior to day 1 of protocol therapy
  • Normal QT interval corrected per Fridericia method (QTcF) on screening electrocardiogram, defined as QTcF of ≤ 480 msec
  • Oxygen (O2) saturation > 90% on room air
  • Seronegative for HIV antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative)
  • 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
  • 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
  • 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
  • Agreement by females and males of childbearing potential to use a highly 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)

Who cannot join

  • Prior treatment failure with asciminib
  • Prior/current treatment with any systemic anticancer therapy (including but not limited to any TKI) and/or radiotherapy for ALL, with the exception of an optional prephase therapy or chemotherapy induction (no more than one cycle), which should be discussed with the principal investigator (PI). Patients who have received no more than two weeks of chemotherapy (not including steroids) with or without other TKIs are considered minimally pretreated and still eligible
  • Currently taking drugs that are known to have a risk of causing prolonged corrected QT interval (QTc) or torsades depointes (TdP) (unless these can be changed to acceptable alternatives or discontinued)
  • Taking any medications or herbal supplements that are known to be strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4 within at least 14 days before the first dose of study drug
  • 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)
Show all 18Show fewer
  • 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)
  • A history of cerebrovascular events such as stroke or transient ischemic attack
  • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome. Treatment with any investigational products within 30 days before enrollment or 6 half-lives of the agent, whichever is shorter
  • History of pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
  • Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)
  • Clinically significant uncontrolled illness
  • Active infection not responding to treatment at the time of starting therapy
  • Autoimmune disease with potential central nervous system (CNS) involvement
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

    Paul Koller, 626-218-2405, pkoller@coh.org

    Paul Koller

Other trials in United States

About this study

Official title: A Phase 1 Study of Asciminib-Based Induction Therapy in Newly Diagnosed Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

This phase I trial studies the side effects and best dose of asciminib when given together with intrathecal (IT) chemotherapy, dexamethasone, vincristine, and blinatumomab (asciminib-based induction therapy) in treating patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Asciminib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as methotrexate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving asciminib-based induction therapy may be safe, tolerable, and/or effective in treating patients with newly diagnosed Ph+ ALL.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluate the safety of asciminib as the tyrosine kinase inhibitor (TKI) backbone in a chemotherapy minimizing induction strategy (dexamethasone, vincristine, IT chemotherapy, blinatumomab).

II. Determine the recommended phase 2 dose (RP2D) of asciminib induction therapy as the TKI backbone in a reduced intensity strategy for the treatment of Ph+ ALL.

SECONDARY OBJECTIVES:

  1. To evaluate the safety and tolerability of an asciminib-based therapy for post-dose limiting toxicity (DLT) cycles.

II. To evaluate the complete molecular response (CMR) rate after 1 and 3 cycles.

III. To evaluate the complete response (CR)/CR with incomplete hematologic recovery (CRi) rate after 1 and 3 cycles.

IV. To evaluate 1-year overall survival and event-free survival rates. V. To evaluate the rate of transplant in patients achieving CR in cycle 1 (CR1).

VI. To evaluate the pharmacokinetics of asciminib in this combination. VII. To evaluate minimal residual disease negativity (MRD-) by clonoSEQ assay (clonoSEQ) after first and third cycles of induction.

EXPLORATORY OBJECTIVE:

  1. Evaluate novel molecular minimal residual disease (MRD) status in plasma and cerebrospinal fluid (CSF).

OUTLINE: This is a dose-escalation study of asciminib in combination with triple IT chemotherapy, dexamethasone, vincristine, and blinatumomab.

Patients receive asciminib orally (PO) once daily (QD) or twice daily (BID) on days 1-28 of cycles 1 and 2 and days 1-42 of cycle 3, triple IT chemotherapy (methotrexate, cytarabine, corticosteroid) on days 1 and 14 of cycles 1 and 2 and days 1, 14, 28, and 42 of cycle 3, dexamethasone PO on days 1-4 and 11-14 of cycle 1, vincristine intravenously (IV) on days 1 and 14 of cycle 1, and blinatumomab IV on days 1-28 of cycle 2 and days 15-42 of cycle 3. Cycles repeat every 28 days (cycles 1 and 2) or 42 days (cycle 3) for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography (ECHO) during screening, blood and CSF sample collection on study, and bone marrow aspiration throughout the study.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 1 year post-treatment start.

Being tested
Asciminib, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Corticosteroid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AsciminibDrug

    Also called ABL 001, ABL-001, ABL001

    Given PO

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood and CSF sample collection

  • BlinatumomabBiological

    Also called AMG 103, AMG-103, AMG103, Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody

    Given IV

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspiration

  • CorticosteroidDrug

    Given IT

  • CytarabineDrug

    Also called .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone

    Given IT

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo ECHO

  • MethotrexateDrug

    Also called Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate

    Given IT

  • VincristineDrug

    Also called LCR, Leurocristine, VCR, Vincrystine

    Given IV

Study groups in NCT07914166
Study groupRoleWhat they receive
Treatment (asciminib-based induction therapy)ExperimentalPatients receive asciminib PO QD or BID on days 1-28 of cycles 1 and 2 and days 1-42 of cycle 3, triple IT chemotherapy on days 1 and 14 of cycles 1 and 2 and days 1, 14, 28, and 42 of cycle 3, dexamethasone PO on days 1-4 and 11-14 of cycle 1, vincristine IV on days 1 and 14 of cycle 1, and blinatumomab IV on days 1-28 of cycle 2 and days 15-42 of cycle 3. Cycles repeat every 28 days (cycles 1 and 2) or 42 days (cycle 3) for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO during screening, blood and CSF sample collection on study, and bone marrow aspiration throughout the study.
Receives: Drug: Asciminib; Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Aspiration; Drug: Corticosteroid; Drug: Cytarabine; Drug: Dexamethasone; Procedure: Echocardiography Test; Drug: Methotrexate; Drug: Vincristine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicity (DLT)

    Toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE), version (v) 6.0.

    Measured: Up to 2 cycles (Cycle length = 28 days)

  2. Maximum tolerated dose/recommended phase 2 dose

    Will be established using a phase 1 queue 3+3 design.

    Measured: Up to the 18.6 months

Secondary outcomes (8)

  1. Incidence of adverse events (AEs)

    The number and percent of patients with AEs will be tabulated by system organ class and preferred term using the Medical Dictionary for Regulatory Activities preferred term dictionary. Observed toxicities will be summarized for the DLT period (cycles 1 and 2), as well as for each of the 3 cycles, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with each study treatment and reversibility or outcome. Listings and narratives will be provided for deaths on study, DLTs/unacceptable toxicities, serious adverse events, and events leading to discontinuation of treatment. Descriptive summaries will also be generated for AE data assessed and graded according to the CTCAE v6.0 grading system.

    Measured: Up to 30 days after last dose of study drug

  2. Complete molecular response

    Will be assessed in accordance with the 2025 National Comprehensive Cancer Network (NCCN) guidelines at each dose level and disease assessment timepoint (cycles 1 and 3). Rates and 95% Clopper-Pearson binomial confidence interval (CI) will be calculated.

    Measured: At the completion of cycle 1 (Cycle length = 28 days) and cycle 3 (Cycle length = 42 days)

  3. Complete response (CR)/CR with incomplete hematologic recovery

    Will be assessed in accordance with the 2025 NCCN guidelines at each dose level and disease assessment timepoint (cycles 1 and 3). Rates and 95% Clopper-Pearson binomial CI will be calculated.

    Measured: At the completion of cycle 1 (Cycle length = 28 days) and cycle 3 (Cycle length = 42 days)

  4. Minimal residual disease negativity

    Will be assessed in accordance with the 2025 NCCN guidelines at each dose level and disease assessment timepoint (cycles 1 and 3). Rates and 95% Clopper-Pearson binomial CI will be calculated.

    Measured: At the completion of cycle 1 (Cycle length = 28 days) and cycle 3 (Cycle length = 42 days)

  5. Rate of allogeneic hematopoietic cell transplantation

    Rates and 95% Clopper-Pearson binomial CI will be calculated.

    Measured: Up to 1 cycle (Cycle length = 28 days)

  6. Overall survival (OS)

    Median OS and 1-year OS rate, will be estimated using the product-limit method of Kaplan-Meier product-limit method and the 95% C.I. of the survival curve will be calculated by the Brookmeyer-Crowley method with log-log transformation.

    Measured: From first study dose to death from any cause or last contact date, whichever comes first, assessed up to 1 year

  7. Progression-free survival (PFS)

    Median PFS and 1-year PFS rate, will be estimated using the product-limit method of Kaplan-Meier product-limit method and the 95% C.I. of the survival curve will be calculated by the Brookmeyer-Crowley method with log-log transformation.

    Measured: Up to 1 year

  8. Concentration of asciminib (Pharmacokinetics)

    Will be assessed over time by descriptive and graphical statistics.

    Measured: Up to 98 days (Cycle 1 and 2 are 28 days each, Cycle 3 is 42 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2026
  2. Study start13 Oct 2027 (estimated)
  3. Primary completion13 Oct 2028 (estimated)
  4. Study completion13 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07914166
Sponsor's protocol ID
25618
Other IDs
NCI-2026-07296, 25618, P30CA033572
Status last verified
Oct 2026
First submitted
21 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Asciminib, Biospecimen Collection and Blinatumomab in people with B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicity (DLT) (time frame: Up to 2 cycles (Cycle length = 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07914166.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in