Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

May 13, 2026 updated by: M.D. Anderson Cancer Center
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives

  • Phase I: To determine the minimum safe and biologically effective dose of asciminib in combination with blinatumomab
  • Phase II: To evaluate the rate of NGS measurable residual disease (MRD) negativity using the clonoSEQ® assay in cohort 1 (newly diagnosed Ph-positive ALL) and the overall response (CR+CRi) rate in cohort 2 (relapsed/refractory disease).

Secondary Objectives

  • To evaluate other clinical efficacy endpoints (complete molecular response [CMR] rate, CR rate, relapse-free survival and overall survival)
  • To determine the safety of the combination regimen

Exploratory Objectives

  • To characterize the role of ABL1 kinase domain mutations on treatment failure and relapse
  • To assess concordance/discordance between MRD assessed by PCR for BCR::ABL1 and next-generation sequencing MRD
  • To determine the effect of the combination regimen on immune cell subsets

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467
        • Not yet recruiting
        • Montefiore Einstein Comprehensive Cancer Center
        • Principal Investigator:
          • Marina Konopleva, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Nicholas Short, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of one of the following:

    a) Participants ≥18 years of age with previously untreated or minimally pretreated Ph-positive ALL who are not suitable candidates for intensive chemotherapy. Participants who have received no more than one or two courses of chemotherapy with or without other TKIs are considered minimally pretreated and still eligible if they have persistently detectable MRD.

    i. If they are in morphologic remission at enrollment, they are evaluable only MRD responses, RFS and OS b) Participants ≥ 12 years of age with relapsed/refractory Ph-positive ALL or with previously treated lymphoid blast phase CML

  2. Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age <18 years
  3. Weight ≥40kg

  4. Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):

    1. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome
    2. Alanine aminotransferase (ALT) ≤ 3 x ULN, OR
    3. Aspartate aminotransferase (AST) ≤ 3 x ULN

  5. Adequate renal function defined as:

    a) Creatinine clearance ≥30 mL/min

  6. Adequate pancreatic function as defined by the following criteria:

    a) Serum lipase and amylase < 1.5 x ULN

  7. Adequate cardiac function as assessed clinically by history and physical examination.
  8. For females of childbearing potential, a negative urine pregnancy test must be documented
  9. Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study participation. For women of child-bearing potential, adequate methods of contraception include: complete abstinence, hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal Ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide
  10. Ability to understand and the willingness to sign a written informed consent document.
  11. Signed informed consent

Exclusion Criteria:

  1. Active serious infection not controlled by oral or intravenous antibiotics.
  2. Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.
  3. Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.
  4. Prolonged QTc interval on pre-entry electrocardiogram (> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist
  5. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. (Participants with active CNS leukemia will NOT be excluded)
  6. Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Cytarabine 2 g/m2 (or alternative) for cytoreduction is permitted.
  7. Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blinatumomab + Asciminib

Participants found to be eligible to take part in this study will receive 5 cycles of blinatumomab and asciminib, followed by asciminib alone for as long as it benefits the participant.

Participants will receive blinatumomab as a continuous (non-stop) infusion on Days 4-31 of Cycle 1 and on Days 1-28 of Cycles 2-5.

Participants will take asciminib by mouth 2 times every day during this study.
Drug: Asciminib
Given by PO
Other Names:
  • ABL001
Drug: Blinatumomab
Given by Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and adverse events (AEs)
Time Frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Nicholas Short, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0054
  • NCI-2024-02121 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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