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

26. april 2026 oppdatert av: 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 .

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

101

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Jiangsu
      • Suzhou, Jiangsu, Kina, 215000
        • Rekruttering
        • The First Affiliated Hospital of Soochow University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Biologisk: 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.
Legemiddel: 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

Legemiddel: Hyper-CVAD

Alternating intensive consolidation chemotherapy:

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

Fremgangsmåte: 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
Biologisk: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
2-year relapse-free survival (RFS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
2-year overall survival (OS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The First Affiliated Hospital of Soochow University

Etterforskere

  • Hovedetterforsker: Suning Chen, The First Affiliated Hospital of Soochow University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2025

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

30. juni 2028

Datoer for studieregistrering

Først innsendt

11. april 2026

Først innsendt som oppfylte QC-kriteriene

26. april 2026

Først lagt ut (Faktiske)

4. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ALL-03

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

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Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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