Full-course immunotherapy plus chemotherapy for newly diagnosed Ph-negative B-cell ALL
Official title: Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
Run by The First Affiliated Hospital of Soochow University · NCT07564453 · Data updated 2026-11-12
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 |
| Ages | 15 Years to 65 Years |
| Sex | All |
| Enrollment | 101 (estimated) |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | blinatumomab, CAR-T, chemotherapy, immunotherapy |
| Locations | 1 site (Suzhou, Jiangsu) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT07564453 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: gloriajlu@163.com
- Phone: 86+0512-67781137
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.