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Philadelphia Chromosome-PositivePhase 1/2NCT06308588

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

A Phase 1/2 study testing Blinatumomab and Asciminib in people with Philadelphia Chromosome-Positive and Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Blinatumomab and Asciminib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
5 Aug 2024to 1 May 2029
Phase
Phase 1/2
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

  • Diagnosis of one of the following:
  • 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.
  • 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
  • Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age <18 years
  • Weight ≥40kg
  • Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):
Show all 18Show fewer
  • Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome
  • Alanine aminotransferase (ALT) ≤ 3 x ULN, OR
  • Aspartate aminotransferase (AST) ≤ 3 x ULN
  • Adequate renal function defined as:
  • Creatinine clearance ≥30 mL/min
  • Adequate pancreatic function as defined by the following criteria:
  • Serum lipase and amylase < 1.5 x ULN
  • Adequate cardiac function as assessed clinically by history and physical examination.
  • For females of childbearing potential, a negative urine pregnancy test must be documented
  • 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
  • Ability to understand and the willingness to sign a written informed consent document.
  • Signed informed consent

Who cannot join

  • Active serious infection not controlled by oral or intravenous antibiotics.
  • 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.
  • Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.
  • Prolonged QTc interval on pre-entry electrocardiogram (> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist
  • 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)
  • 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.
  • 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.

Trial locations and contacts

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

Nicholas Short, MD contact

(713) 563-4485

nshort@mdanderson.org

United States2 sites, 2 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Nicholas Short, MD, 713-563-4485, nshort@mdanderson.org

    Nicholas Short, MD

    Recruiting

  • Montefiore Einstein Comprehensive Cancer Center

    The Bronx, New York, 10467

    Marina Konopleva, MD, 718-920-4826, Marina.Konopleva@einsteinmed.edu

    Marina Konopleva, MD

    Not yet recruiting

Other trials in United States

About this study

To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.

Read the 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
Being tested
Blinatumomab, Asciminib
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • BlinatumomabDrug

    Given by Infusion

  • AsciminibDrug

    Also called ABL001

    Given by PO

Study groups in NCT06308588
Study groupRoleWhat they receive
Blinatumomab + AsciminibExperimentalParticipants 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.
Receives: Drug: Blinatumomab; Drug: Asciminib

What is being measured

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

  1. Safety and adverse events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year.

Timeline

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

  1. First posted13 Mar 2024
  2. Study start5 Aug 2024
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2029 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06308588
Sponsor's protocol ID
2024-0054
Other IDs
NCI-2024-02121
Status last verified
Oct 2026
First submitted
7 Mar 2024
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.

    PubMed 41671463

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Blinatumomab and Asciminib in people with Philadelphia Chromosome-Positive and Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 2 sites 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 18 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 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 2 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Nicholas Short, MD ((713) 563-4485, nshort@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). 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 NCT06308588, which also lists 1 linked publication.

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 2 Nov 2026.

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