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NCT Number: NCT07564453

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

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 .

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Key information

Conditions

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Tumor Virus Infections Virus Diseases

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location status: Recruiting

Location contact

Jing Lu

CONTACT

[email protected]

86+0512-67781137

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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

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

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.

Primary outcomes

  1. 2-year relapse-free survival (RFS)

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

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

Secondary outcomes

  1. 2-year overall survival (OS)

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

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

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

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

    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)

  3. Minimal Residual Disease (MRD) Negativity Rate

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Lu Doctor

CONTACT

[email protected]

86+0512-67781137

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Acronym: FLOW

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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