NCT07564453 Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
| NCT ID | NCT07564453 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative |
| Study Type | INTERVENTIONAL |
| Enrollment | 101 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 101 participants in total. It began in 2025-04-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 .
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
Contact & Investigator
Suning Chen
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT07564453 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 65 Years, studying B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07564453 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07564453 currently recruiting?
Yes, NCT07564453 is actively recruiting participants. Contact the research team at gloriajlu@163.com for enrollment information.
Where is the NCT07564453 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07564453 clinical trial?
NCT07564453 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Suning Chen at The First Affiliated Hospital of Soochow University. The trial plans to enroll 101 participants.
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