Full-course immunotherapy plus chemotherapy for newly diagnosed Ph-negative B-cell ALL

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

This phase 2 test gives blinatumomab throughout treatment with reduced-dose chemotherapy, and uses CAR-T cells and transplant as needed, to try to improve two-year relapse-free survival in adults with newly diagnosed Ph-negative B-cell ALL.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (estimated)
• Ages: 15 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: blinatumomab, CAR-T, chemotherapy, immunotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07564453 on ClinicalTrials.gov

What this trial studies

This is a single-arm, prospective phase 2 program at The First Affiliated Hospital of Soochow University that combines full-course blinatumomab with a reduced-dose chemotherapy backbone. Induction uses reduced-dose chemotherapy plus blinatumomab to improve remission rates and tolerability. Consolidation alternates Hyper-CVAD A/B with additional blinatumomab and sequential CD19-directed CAR-T therapy to deepen MRD clearance, with allo‑HSCT reserved for selected high‑risk or persistent‑MRD patients; no maintenance therapy is planned. The primary endpoint is two-year relapse-free survival, with secondary endpoints including two-year overall survival, MRD outcomes, and safety measures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 15–65 with newly diagnosed Philadelphia chromosome–negative CD19+ B-cell precursor ALL who are treatment‑naïve (except brief hydroxyurea/corticosteroids), have ECOG 0–3, and meet organ function criteria.

Not a fit: Patients unlikely to benefit include those with Ph+ ALL, T‑cell or mature B‑cell leukemias, mixed phenotype leukemias, CNS leukemic involvement, very poor organ function, age outside 15–65, or inadequate CD19 expression.

Why it matters

Potential benefit: If successful, this approach could increase durable remissions and reduce two-year relapse rates by improving MRD clearance while limiting chemotherapy toxicity.

How similar studies have performed: Blinatumomab and CD19 CAR‑T have each improved MRD clearance and outcomes in relapsed/refractory or MRD‑positive B‑ALL, but using blinatumomab as a full-course backbone combined with routine sequential CAR‑T and reduced‑dose chemotherapy is a relatively novel strategy not yet widely validated.

Eligibility criteria

Inclusion Criteria:

1. Age ≥15 years and ≤65 years.
2. Newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) according to WHO diagnostic criteria, with CD19 expression ≥ 20%
3. De novo patients with no prior induction therapy (excluding hydroxyurea and corticosteroid use for ≤ 5 days)
4. ECOG performance status score 0-3.
5. 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).
6. Renal function: Creatinine clearance rate (CrCl) ≥ 30 mL/min
7. Able to understand and voluntarily participate in the study, and provide written informed consent

Exclusion Criteria:

1. Philadelphia chromosome-positive (Ph+, BCR-ABL1+) ALL
2. T-cell acute lymphoblastic leukemia
3. Mature B-cell leukemia/lymphoma, B-cell lymphoblastic lymphoma, extramedullary invasion
4. Acute mixed phenotype acute leukemia (MPAL)
5. Central nervous system (CNS) leukemia
6. HIV infection
7. Positive HBV-DNA or HCV-RNA
8. New York Heart Association (NYHA) functional class ≥ II, or other conditions deemed unsuitable for enrollment by the investigator
9. Pregnant or lactating patients
10. Patients who refuse to enroll in the study

Where this trial is running

Suzhou, Jiangsu

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

Study contacts

• Principal investigator: Suning Chen — The First Affiliated Hospital of Soochow University
• Study coordinator: Jing Lu Doctor

Conditions B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative; Blinatumomab