Comparing Blinatumomab with hyperCVAD for treating Philadelphia-negative B-ALL

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 the effectiveness of Blinatumomab combined with reduced-intensity chemotherapy versus the hyperCVAD regimen in newly diagnosed patients with Philadelphia-negative B-cell acute lymphoblastic leukemia (B-ALL). Participants aged 15-65 are randomly assigned to one of the two treatment groups, and outcomes such as clinical remission rates, minimal residual disease (MRD) negativity, and treatment-related adverse effects are evaluated. The study aims to determine if the combination of Blinatumomab with less intensive chemotherapy can improve patient outcomes while reducing toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 15-65
* Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria
* Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days
* ECOG score 0-3
* Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine ·aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration)
* Renal function: endogenous creatinine clearance ≧30ml/min
* Patients must be able to understand and willing to participate in the study and must sign the informed consent form.

Exclusion Criteria:

* Ph+ (BCR-ABL1 positive) ALL
* T cells ALL
* Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease
* Acute mixed-cell leukemia
* Central nervous system leukemia
* HIV infection
* HBV-DNA or HCV-RNA positive
* Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator
* Pregnant or breastfeeding patients
* The study patient was refused enrollment

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Jing Lu, MD — Soochow U
• Study coordinator: Jing Lu
• Email: lujing@suda.edu.cn
• Phone: 1377183627

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.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07677878

• 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.

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• 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

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  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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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.