Phase II Clinical TrialPhase 2NCT07178912

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)

A Phase 2 study testing Blinatumomab and olverembatinib in people with Phase II Clinical Trial and Blinatumomab, run by M.D. Anderson Cancer 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

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Phase II Clinical Trial, Blinatumomab, Olverembatinib
What is being tested?: Blinatumomab and olverembatinib
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 27 Jan 2027to 30 Sep 2033
Phase: Phase 2

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

None listed.

Who cannot join

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

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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.

Trial locations and contacts

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

Elias J Jabbour, MD contact

713-792-4764

ejabbour@mdanderson.org

United States1 site

MD Anderson Cancer Center
Houston, Texas, 77030
Elias j Jabbour, MD, 713-792-4764, ejabbour@mdanderson.org
Elias J Jabbour, MD

Other trials in United States

About this study

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.

Read the detailed description

Primary Objective

To evaluate the rate of complete molecular response (CMR; undetectable BCR::ABL1 transcript by RT-PCR) in participants with newly diagnosed Ph-positive ALL and the overall response rate (complete remission + complete remission with incomplete count recovery) in participants with relapsed/refractory Ph-positive ALL

Secondary Objectives

To evaluate event-free survival (EFS)
To evaluate overall survival (OS)
To evaluate MRD negativity by next-generation sequencing (NGS) at a sensitivity of 1x10-6
To assess the safety of the regimen

Conditions: Phase II Clinical Trial, Blinatumomab, Olverembatinib, Lymphoblastic Leukemia, Philadelphia Chromosome Positive
Being tested: Blinatumomab, olverembatinib
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 Iv
olverembatinibDrug
Given by PO

Study groups in NCT07178912
Study group	Role	What they receive
Treatment with Blinatumomab (SC) + Olverembatinib (PO) Q5W	Experimental	Patients will be receiving blinatumomab and olverembatinib. Receives: Drug: Blinatumomab; Drug: olverembatinib

What is being measured

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

safety and adverse events
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.

27 Jan 202730 Sep 2033

First posted17 Sep 2025
Study start27 Jan 2027 (estimated)
Primary completion30 Sep 2031 (estimated)
Study completion30 Sep 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Phase II Clinical TrialStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07178912
Sponsor's protocol ID: 2025-0934
Other IDs: NCI-2025-06675
Status last verified: Sep 2026
First submitted: 10 Sep 2025
Last updated: 7 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No