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

April 26, 2026 updated by: Chen Suning, The First Affiliated Hospital of Soochow University

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • the First Affiliated Hospital of Soochow University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm:Blinatumomab + Chemotherapy
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
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.
Drug: Induction Chemotherapy

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

Drug: Hyper-CVAD

Alternating intensive consolidation chemotherapy:

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

Procedure: Allogeneic hematopoietic stem cell transplantation
Allogeneic hematopoietic stem cell transplantation, performed after consolidation therapy in patients with KMT2A rearrangement, TP53 mutation, persistent MRD positivity or MRD recurrence
Biological: CAR-T cell therapy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment through 2 years post-last patient enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment through 2 years post-last patient enrolled
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)
From randomization to 2 cycles of induction before consolidation therapy(100 days)
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.
From randomization to 2 cycles of induction before consolidation therapy(100 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Suning Chen, the First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

April 11, 2026

First Submitted That Met QC Criteria

April 26, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALL-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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