Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia

Recruiting now · Phase 2

Conditions studied: B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

In brief

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 .

Key facts

Study ID: NCT07564453
Run by: The First Affiliated Hospital of Soochow University
People needed: 101
Starts: 2025-04-01
Expected to finish: 2028-06-30
Last updated by the study team: 2026-05-04

Who can join

Age: 15 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
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
Pregnant or lactating patients
Patients who refuse to enroll in the study

Where it is running

The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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