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

ConditionB Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15-65
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Blinatumomab

    Biological/Vaccine

    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.

  • 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

  • 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

  • Allogeneic hematopoietic stem cell transplantation

    Procedure/Surgery

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

  • CAR-T cell therapy

    Biological/Vaccine

    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.

Treatment groups

101 Participants
are divided into 1 treatment group
Group A: Experimental Arm:Blinatumomab + ChemotherapyExperimental treatment 5 interventions

Trial outcomes

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.

Time frame
From enrollment through 2 years post-last patient enrolled

Secondary outcomes

1

2-year overall survival (OS)

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

Time frame
From enrollment through 2 years post-last patient enrolled
2

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

Proportion of patients achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) after induction phase.CRc is evaluated at: 1) Day 22 after initial induction therapy; 2) After re-induction with blinatumomab for 2 weeks (for patients not achieving CRc at Day 22)

Time frame
From randomization to 2 cycles of induction before consolidation therapy(100 days)
3

Minimal Residual Disease (MRD) Negativity Rate

Proportion of patients achieving MRD negativity (detected by next-generation sequencing, NGS, sensitivity ≥10-⁵) at multiple time points: after first Hyper-CVAD-B chemotherapy, after second Hyper-CVAD-B chemotherapy, and after CD19-CART2 therapy. MRD negativity is defined as \<10-⁵ leukemic blasts in bone marrow.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov
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