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.
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
- 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
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
Show all 21Show fewer
- 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.
United States1 site
MD Anderson Cancer Center
Houston, Texas, 77030
Elias j Jabbour, MD, 713-792-4764, ejabbour@mdanderson.org
Elias J Jabbour, MD
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Ascentage Pharma Group Inc.
- Responsible party
- Sponsor
- Investigators
- Elias J Jabbour, MD, Principal investigator, M.D. Anderson Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07178912
- Acronym / sponsor ID
- 2025-0934
- Conditions
- Phase II Clinical Trial, Blinatumomab, Olverembatinib, Lymphoblastic Leukemia, Philadelphia Chromosome Positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen, Ascentage Pharma Group Inc.
- Study start
- 27 Jan 2027 (estimated)
- Primary completion
- 30 Sep 2031 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Blinatumomab (SC) + Olverembatinib (PO) Q5W | Experimental | Drug: Blinatumomab, Drug: olverembatinibPatients will be receiving blinatumomab and olverembatinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlinatumomabGiven by Iv | Drug | Treatment with Blinatumomab (SC) + Olverembatinib (PO) Q5W |
| olverembatinibGiven by PO | Drug | Treatment with Blinatumomab (SC) + Olverembatinib (PO) Q5W |
Primary outcome
safety and adverse events
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elias J Jabbour, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 0 inclusion and 21 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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 Elias J Jabbour, MD (713-792-4764, ejabbour@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 (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?
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 7 Oct 2026.