Combining Blinatumomab with Reduced-dose Chemotherapy for B-ALL Treatment
Blinatumomab Combined With Reduced-dose Chemotherapy in Treating Precursor B Cell Acute Lymphoblastic Leukemia: a Phase II, Single Arm and Multicenter Study
This study is testing a new treatment that combines Blinatumomab with lower doses of chemotherapy to see if it helps adults with a type of leukemia called precursor B-cell acute lymphoblastic leukemia feel better and achieve a complete response.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 15 Years to 59 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Drugs / interventions | Blinatumomab, chemotherapy, immunotherapy, Cyclophosphamide |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06742515 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a new treatment approach for adults with precursor B-cell acute lymphoblastic leukemia (B-ALL) by combining Blinatumomab with reduced-dose chemotherapy. The study is a phase II, single-arm, open-label trial that aims to enroll 20 participants who are Philadelphia chromosome-negative. The primary goal is to evaluate the safety and efficacy of this treatment regimen, focusing on achieving a minimal residual disease (MRD)-negative complete response. Participants will receive a combination of Blinatumomab, Vindesine, Cyclophosphamide, and Dexamethasone, followed by Venetoclax in the second cycle, with the potential for bone marrow transplantation as consolidation therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 15 to 59 years diagnosed with de novo precursor B-cell acute lymphoblastic leukemia who are Philadelphia chromosome-negative.
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 improve survival rates for adults with B-ALL.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in treating B-ALL, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Before enrollment, patients must be diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and be negative for Philadelphia chromosome. The diagnostic criteria refer to the 2022 WHO classification; 2. Age≥15 years， ≤59 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 4. Expected survival time ≥ 2 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. Unable 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 310003 — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Jie Jin, M.D.
- Email: jiej0503@163.com
- Phone: +8657187236896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.