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)

NCT07178912 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025-0934NCI-2025-06675
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Phase II Clinical Trial; Philadelphia Chromosome Positive; Blinatumomab; Olverembatinib; Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year

Study Arms (1)

Treatment with Blinatumomab (SC) + Olverembatinib (PO) Q5W

EXPERIMENTAL

Patients will be receiving blinatumomab and olverembatinib.

Drug: Blinatumomab; Drug: olverembatinib

Interventions

Blinatumomab DRUG

Given by Iv

Treatment with Blinatumomab (SC) + Olverembatinib (PO) Q5W

olverembatinib DRUG

Given by PO

Treatment with Blinatumomab (SC) + Olverembatinib (PO) Q5W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Amgen: collaborator
• Ascentage Pharma Group Inc.: collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

blinatumomab; olverembatinib

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Elias J Jabbour, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elias J Jabbour, MD

CONTACT

713-792-4764; ejabbour@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start (Estimated): August 27, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2033
• Last Updated: May 5, 2026

Record last verified: 2026-03

Locations

US (1)