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)

Starting soon · Phase 2

Conditions studied: Phase II Clinical Trial, Blinatumomab, Olverembatinib, Lymphoblastic Leukemia, Philadelphia Chromosome Positive

In brief

To find out if giving blinatumomab as injections under the skin and olverembatinib can help to control the disease in patients with Ph-positive ALL.

Key facts

Study ID

NCT07178912

Run by

M.D. Anderson Cancer Center

People needed

60

Starts

2026-08-27

Expected to finish

2033-09-30

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.
• Active grade III-V cardiac failure as defined by the New York Heart Association criteria.
• 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.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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