Combining Blinatumomab and Venetoclax with Inotuzumab Ozogamicin for B-ALL Treatment

The Regimen of Blinatumomab and Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating Precursor B Cell Acute Lymphoblastic Leukemia: A Phase II, Single Arm and Multicenter Study

This study is testing a new combination of three medications to see if it can help adults with newly diagnosed B-cell acute lymphoblastic leukemia live longer and healthier lives.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Drugs / interventions: Blinatumomab, Inotuzumab, chemotherapy, immunotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06554626 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a novel treatment regimen for adults with newly diagnosed precursor B-cell acute lymphoblastic leukemia (B-ALL) that combines Blinatumomab, Venetoclax, and Inotuzumab Ozogamicin. The study is a prospective, single-arm, phase II trial aiming to evaluate the safety and efficacy of this multi-drug approach. Participants will undergo induction therapy followed by consolidation and maintenance phases, with a primary endpoint of 2-year event-free survival. The goal is to improve survival rates in this aggressive leukemia population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with newly diagnosed Philadelphia chromosome-negative precursor B-ALL.

Not a fit: Patients with central nervous system involvement of ALL or significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance survival outcomes for adults with precursor B-ALL.

How similar studies have performed: Other studies have shown promising results with similar multi-drug combinations in treating B-ALL, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Before enrollment, a diagnosis of newly diagnosed precursor B-cell acute lymphoblastic leukemia with Philadelphia chromosome-negative must be confirmed. The diagnostic criteria refer to the 2022 WHO classification.
2. Age ≥ 40 years;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
4. Expected survival time ≥ 3 months;
5. No organ dysfunction that would restrict the use of this protocol during the screening period;
6. Understand the study and sign the informed consent form.
7. Men, women of childbearing age (only postmenopausal women who have been menopausal for at least 12 months can be considered infertile), and their partners voluntarily take effective contraceptive measures deemed effective by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.

Exclusion Criteria:

1. Patients with known central nervous system (CNS) involvement of ALL;
2. Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.);
3. Cardiac ultrasound LVEF \< 45%;
4. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
5. Serum total bilirubin \> 1.5 ULN (upper limit of normal); ALT or AST \> 2.5 ULN; serum creatinine \> 1.5 ULN;
6. Known HIV infection;
7. Conditions affecting the use of the study drug as assessed by the investigator;
8. Inability to understand or comply with the study protocol.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Jie Jin, M.D.

Conditions Precursor B-Cell Lymphoblastic Leukemia