Blinatumomab with Chemotherapy for Newly Diagnosed Philadelphia-Negative B-cell Acute Lymphoblastic Leukemia
Tests blinatumomab with chemotherapy in people newly diagnosed with B-cell acute lymphoblastic leukemia.
Plain-language title generated from the registry record
Registry title: Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 15 and 65 years old?
Source: NCT07564453, who can take part
Where in China
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT07564453
- Record updated
- 4 May 2026
- Original description
This is a single-arm, prospective, phase 2 clinical trial evaluating the improvement of survival outcomes of blinatumomab combined with chemotherapy as a full-course treatment regimen in patients with newly diagnosed Philadelphia chromosome-negative (Ph-negative) B-cell precursor acute lymphoblastic leukemia (B-ALL). The study adopts a "reduced-dose chemotherapy + full-course immunotherapy" strategy: induction therapy with reduced-dose chemotherapy combined with blinatumomab to improve remission rate and tolerability; consolidation therapy with alternating Hyper-CVAD (A/B) regimen，blinatumomab and sequential CD19-directed CAR-T therapy to deepen minimal residual disease (MRD) clearance; allogeneic hematopoietic stem cell transplantation (allo-HSCT) for some patients (e.g., KMT2A rearrangement, TP53 mutation, persistent MRD positivity, MRD recurrence); and no maintenance therapy.Read full original descriptionShow less
Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
This is a single-arm, prospective, phase 2 clinical trial evaluating the improvement of survival outcomes of blinatumomab combined with chemotherapy as a full-course treatment regimen in patients with newly diagnosed Philadelphia chromosome-negative (Ph-negative) B-cell precursor acute lymphoblastic leukemia (B-ALL). The study adopts a "reduced-dose chemotherapy + full-course immunotherapy" strategy: induction therapy with reduced-dose chemotherapy combined with blinatumomab to improve remission rate and tolerability; consolidation therapy with alternating Hyper-CVAD (A/B) regimen，blinatumomab and sequential CD19-directed CAR-T therapy to deepen minimal residual disease (MRD) clearance; allogeneic hematopoietic stem cell transplantation (allo-HSCT) for some patients (e.g., KMT2A rearrangement, TP53 mutation, persistent MRD positivity, MRD recurrence); and no maintenance therapy.
The primary endpoint is 2-year relapse-free survival (RFS). Secondary endpoints include 2-year overall survival (OS), the proportion and time to achieve complete response (CRc), and the proportion and time to achieve minimal residual disease (MRD) negativity.
The trial plans to enroll 101 patients aged 15-65 years to demonstrate improved survival outcomes compared with historical controls .
Inclusion: Age ≥15 years and ≤65 years; Newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) according to WHO diagnostic criteria, with CD19 expression ≥ 20%; De novo patients with no prior induction therapy (excluding hydroxyurea and corticosteroid use for ≤ 5 days); ECOG performance status score 0-3; Liver function: Total bilirubin ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3×ULN; aspartate transaminase (AST) ≤ 3×ULN; (leukemic infiltration is excluded); Renal function: Creatinine clearance rate (CrCl) ≥ 30 mL/min; Able to understand and voluntarily participate in the study, and provide written informed consent.
Exclusion: HIV infection; Positive HBV-DNA or HCV-RNA; New York Heart Association (NYHA) functional class ≥ II, or other conditions deemed unsuitable for enrollment by the investigator; Philadelphia chromosome-positive (Ph+, BCR-ABL1+) ALL; T-cell acute lymphoblastic leukemia; Mature B-cell leukemia/lymphoma, B-cell lymphoblastic lymphoma, extramedullary invasion; Acute mixed phenotype acute leukemia (MPAL); Central nervous system (CNS) leukemia; Pregnant or lactating patients; Patients who refuse to enroll in the study.