Combining Blinatumomab with Reduced-dose Chemotherapy for B-ALL Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Blinatumomab plus low-dose donor cells after transplant for high-risk B-ALL

  This small, early-phase study tests whether giving blinatumomab with low-dose donor lymphocytes after allogeneic transplant is safe and helps long-term survival for people with high-risk B-ALL.

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• LP-118 in combination with standard therapy for newly diagnosed Ph+ ALL

  This study tests whether adding LP-118 to the standard therapy for adults with Philadelphia chromosome–positive ALL is safe and useful.

  Recruiting at 2 sites Phase 1 Wake Forest University Health Sciences · Charlotte, North Carolina and 1 other locations · NCT07614022

• MK-1045 versus blinatumomab for relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia

  This trial will test whether MK-1045 helps people with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia more than the standard immunotherapy blinatumomab.

  Recruiting at 30 sites Phase 2/3 Merck Sharp & Dohme LLC · Toronto, Ontario and 29 other locations · NCT07570173

• Vaccine protection after blinatumomab in children with B-ALL

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• Asciminib in children and young adults with relapsed or refractory Ph+ or ABL-class Ph-like ALL

  This study tests asciminib in kids and young adults with relapsed or refractory Philadelphia-positive or ABL-class Ph-like ALL to see if it is safe and helps treat the leukemia.

  Recruiting at 4 sites Phase 1/2 Novartis · Sydney, New South Wales and 3 other locations · NCT07387926

• Subcutaneous blinatumomab treatment for adults with CD19-positive mixed phenotype acute leukemia

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  Recruiting Phase 2 West Virginia University · Morgantown, West Virginia · NCT07222579

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.