Comparing Blinatumomab with hyperCVAD for treating Philadelphia-negative B-ALL
Comparing the Efficacy and Safety of Reduced-dose Chemotherapy Followed by Blinatumomab Versus hyperCVAD as Induction Therapy for Newly Diagnosed Ph-negative B-ALL: a Multicenter, Radomized, Phase 2 Study
This study is testing if combining Blinatumomab with lighter chemotherapy can help young adults with a type of leukemia feel better and have fewer side effects compared to a standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 15 Years to 65 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | Blinatumomab, chemotherapy, Methotrexate |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06250959 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed patients aged 15-65 with Philadelphia-negative B-ALL who have not received prior induction therapy.
Not a fit: Patients with Philadelphia-positive B-ALL, T-cell ALL, or other specified exclusions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved remission rates and reduced side effects for patients with Philadelphia-negative B-ALL.
How similar studies have performed: Previous studies have shown promising results for Blinatumomab in treating relapsed/refractory B-ALL, suggesting potential success for this novel approach in newly diagnosed patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Suzhou, Jiangsu
- 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
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.