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

NCT07564453 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ALL-03
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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 .

Conditions

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

Keywords

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative; Blinatumomab

Outcome Measures

Primary Outcomes (1)

• 2-year relapse-free survival (RFS)

  Defined as the time from enrollment to relapse, death from any cause, or last follow-up, whichever occurs first.

  From enrollment through 2 years post-last patient enrolled

Secondary Outcomes (3)

• 2-year overall survival (OS)

  From enrollment through 2 years post-last patient enrolled

• Composite Complete Remission (CR/CRi) Rate after Induction Therapy

  From randomization to 2 cycles of induction before consolidation therapy(100 days)

• Minimal Residual Disease (MRD) Negativity Rate

  From randomization to 2 cycles of induction before consolidation therapy(100 days)

Study Arms (1)

Experimental Arm:Blinatumomab + Chemotherapy

EXPERIMENTAL

Patients receive reduced-dose chemotherapy combined with blinatumomab for induction, followed by alternating Hyper-CVAD(A/B) chemotherapy, blinatumomab and sequential CD19-directed CAR-T therapy for consolidation. Patients (e.g., KMT2A rearrangement, TP53 mutation, persistent MRD positivity, MRD recurrence)receive allogeneic hematopoietic stem cell transplantation.

Biological: Blinatumomab; Drug: Induction Chemotherapy; Drug: Hyper-CVAD; Procedure: Allogeneic hematopoietic stem cell transplantation; Biological: CAR-T cell therapy

Interventions

Blinatumomab BIOLOGICAL

Induction phase: 9 µg/day on days 8-14, 28 µg/day on days 15-21; If D22 BM not CR/CRi, continue Blinatumomab for next 2 weeks of 28 µg/day; Consolidation phase: 28 µg/day for 28 days.

Experimental Arm:Blinatumomab + Chemotherapy

Induction Chemotherapy DRUG

Reduced-dose induction regimen: Idarubicin 8 mg/m², intravenous, day 1; Vindesine 3 mg/m² (max 4 mg), intravenous, day 1; Dexamethasone 9 mg/m²/day, intravenous, days 1-7. Combined with blinatumomab

Experimental Arm:Blinatumomab + Chemotherapy

Hyper-CVAD DRUG

Alternating intensive consolidation chemotherapy: Hyper-CVAD-A: Cyclophosphamide ,Vincristine , Doxorubicin , Dexamethasone ; Hyper-CVAD-B: Methotrexate , Cytarabine . Alternated with CD19-CART and blinatumomab

Experimental Arm:Blinatumomab + Chemotherapy

Allogeneic hematopoietic stem cell transplantation PROCEDURE

Allogeneic hematopoietic stem cell transplantation, performed after consolidation therapy in patients with KMT2A rearrangement, TP53 mutation, persistent MRD positivity or MRD recurrence

Experimental Arm:Blinatumomab + Chemotherapy

CAR-T cell therapy BIOLOGICAL

CD19-CART is administered sequentially in the consolidation phase: First infusion : Following the first course of blinatumomab (28 µg/day, IV, days 1-28) before subsequent Hyper-CVAD chemotherapy. Second infusion : After completion of alternating Hyper-CVAD and blinatumomab consolidation cycles.

Experimental Arm:Blinatumomab + Chemotherapy

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

blinatumomab; Induction Chemotherapy; CVAD protocol; Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction; Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Immunologic Techniques; Investigative Techniques

Study Officials

• Suning Chen

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Lu Doctor

CONTACT

86+0512-67781137; gloriajlu@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: May 4, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CN (1)