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Phase II Study of Blinatumomab and Olverembatinib for Ph-Positive ALL

This study is testing a combination of two drugs, blinatumomab and olverembatinib, for people with Philadelphia chromosome (Ph)-positive and/or BCR::ABL1-positive acute lymphoblastic leukemia (ALL). Blinatumomab is given as an injection under the skin, and olverembatinib is taken by mouth. The main goal is to see how safe this combination is and to track any side effects. Researchers also want to see if the treatment can lead to a complete molecular response (meaning no detectable leukemia cells) in newly diagnosed patients, or an overall response (meaning the leukemia is controlled) in those whose ALL has returned or is difficult to treat. You might be able to join if you are 18 or older and have newly diagnosed or relapsed/refractory Ph-positive and/or BCR::ABL1-positive ALL. The study is currently unclear on its recruitment status and plans to enroll 60 participants.

Study design
This is an interventional study with a planned enrollment of 60 participants. It is a Phase II clinical trial.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of 1 year.

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NCT07178912

Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~60 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Blinatumomabolverembatinib

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
safety and adverse events
Measured over Through study completion; an average of 1 year

Conditions

Phase II Clinical Trial
Blinatumomab
Olverembatinib
Lymphoblastic Leukemia
Philadelphia Chromosome Positive

Explore related trials

Acute Lymphoblastic LeukemiaChronic Myeloid Leukemia, BCR-ABL1 Positivet(9;22)(q34.1;q11.2)

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Elias J Jabbour, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Elias J Jabbour, MD
[email protected]
713-792-4764
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Active serious infection not controlled by oral or IV 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.
Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
Myocardial infarction, stroke, or revascularization within 3 months
Unstable angina or transient ischemic attack
Congestive heart failure prior to enrollment, or left ventricular ejection fraction less than lower limit of normal per local institutional standards prior to enrollment
Diagnosed or suspected congenital long QT syndrome
Clinically significant atrial or ventricular arrhythmias (such as atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician
Prolonged QTc interval on pre-entry electrocardiogram (\>470 msec) unless corrected after electrolyte replacement or approved by cardiologist
Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Participants with a history of treated prior superficial or catheter associated thrombosis will not be considered as significant embolism and after discussion with PI will not be excluded from eligibility
Uncontrolled hypertension (diastolic blood pressure \>90 mmHg, systolic \>140 mmHg). Participants with hypertension should be under treatment on study entry for blood pressure control.
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.
Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
Treatment with any investigational antileukemic agent or chemotherapy agent in the last 7 days before study entry, unless full recovery from side effects has occurred or Participant has rapidly progressive disease judged to be life-threatening by the investigator.
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.
History of significant bleeding disorder unrelated to cancer, including:
Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).
Participants with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia.

What this trial measures

  • safety and adverse eventsThrough 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