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A Phase 2 Study of Bcl-2 Inhibitor Combined With Azacitidine for Newly Diagnosed Mixed Phenotype Acute Leukemia

1. mai 2026 oppdatert av: Chen Suning, The First Affiliated Hospital of Soochow University

A Prospective, Open-Label, Single-Arm, Two-Cohort Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Bcl-2 Inhibitor Combined With Azacitidine in the Treatment of Newly Diagnosed Mixed Phenotype Acute Leukemia

This is a prospective, open-label, single-arm, two-cohort Phase 2 clinical study designed to evaluate the efficacy and safety of Bcl-2 Inhibitor combined with azacitidine (with blinatumomab added in B/myeloid subtype) in patients with newly diagnosed mixed phenotype acute leukemia (MPAL). Eligible subjects are divided into two cohorts based on immunophenotype: Cohort A (T/Myeloid MPAL) receives Bcl-2 Inhibitor + azacitidine, and Cohort B (B/Myeloid MPAL) receives Bcl-2 Inhibitor + azacitidine + blinatumomab. The treatment cycle is 28 days, with the primary efficacy endpoint assessed after 2 cycles of induction therapy. Patients who achieve CRc will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) following 2 to 3 cycles of consolidation therapy.The total enrollment period is 24 months, and all subjects will be followed up for at least 24 months from the first day of the first cycle (C1D1).

The primary objective is to evaluate the composite complete response (CRc) rate after 2 cycles of induction therapy , and the secondary objectives include evaluating measurable residual disease (MRD) negativity rate, bridge-to-allogeneic hematopoietic stem cell transplantation (allo-HSCT) rate in first complete response (CR1), overall survival(OS),Event-Free Survival(EFS),Relapse-Free Survival(RFS) and Safety.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

52

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
        • The First Affiliated Hospital of Soochow University

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. Aged 16 to 70 years old
  2. Newly diagnosed MPAL confirmed by the 2022 WHO/ICC classification criteria for hematopoietic and lymphoid neoplasms
  3. Previously untreated; use of glucocorticoids or hydroxyurea for ≤7 days to control tumor burden before enrollment is allowed, no other systemic anti-leukemia therapy
  4. ECOG performance status score 0-3
  5. No severe combined heart, brain, lung, liver or kidney disease, judged by the investigator to tolerate the study regimen
  6. Able to understand and voluntarily sign a written informed consent form

Exclusion Criteria:

  1. BCR::ABL-positive MPAL patients
  2. Presence of active, uncontrolled infection
  3. Known uncontrolled active central nervous system leukemia (CNSL)
  4. Life-threatening extramedullary disease requiring urgent radiotherapy or surgical debulking
  5. Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) <40%
  6. Previous receipt of systemic anti-leukemia therapy
  7. Pregnant or lactating female subjects
  8. Judged by the investigator to be ineligible for the study for other reasons

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: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cohort A: T/Myeloid MPAL

Sonrotoclax: 40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral; Azacitidine: 75mg/m² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles.

Patients who achieve CRc will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) following 2 to 3 cycles of consolidation therapy.
Legemiddel: BCL-2 indibitor

Sonrotoclax:40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral;

  • 2 cycles.
Andre navn:
  • Sonrotoclax
Legemiddel: Azacitidine (AZA)
75mg/m² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles
Andre navn:
  • Azacitidin
Eksperimentell: Cohort B: B/Myeloid MPAL

Sonrotoclax: 40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral; Azacitidine: 75mg/m² qd (D1-D7), subcutaneous injection; Blinatumomab: 9μg/day (D8-D14), 28μg/day (D15-D21), continuous intravenous infusion; 28-day cycle, ≥2 cycles.

Patients who achieve CRc will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) following 2 to 3 cycles of consolidation therapy.
Legemiddel: BCL-2 indibitor

Sonrotoclax:40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral;

  • 2 cycles.
Andre navn:
  • Sonrotoclax
Legemiddel: Azacitidine (AZA)
75mg/m² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles
Andre navn:
  • Azacitidin
Legemiddel: Blinatumomab
9μg/day (D8-D14), 28μg/day (D15-D21), continuous intravenous infusion

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Composite Complete Response (CRc) rate after 2 cycles of induction therapy
Tidsramme: From randomization to 2 cycles of induction before consolidation therapy（100 days）
CRc = CR + CRi; CR: bone marrow blasts <5%, no extramedullary disease, no peripheral blasts, ANC ≥1.0×10⁹/L, PLT ≥100×10⁹/L; CRi: bone marrow blasts <5%, no extramedullary disease, no peripheral blasts, incomplete hematologic recovery (ANC <1.0×10⁹/L or PLT <100×10⁹/L)
From randomization to 2 cycles of induction before consolidation therapy（100 days）

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
MRD negativity rate
Tidsramme: From randomization to 2 cycles of induction before consolidation therapy（100 days）
Bone marrow MRD <0.01% detected by MFC
From randomization to 2 cycles of induction before consolidation therapy（100 days）
NGS-MRD negativity rate
Tidsramme: From randomization to 2 cycles of induction before consolidation therapy（100 days）, and test Every 3 months during follow-up
NGS-MRD can not detected by IgH/TCR NGS (NGS-based MRD will be incorporated as an exploratory complementary assay in patients with trackable clonotypic rearrangements at diagnosis)
From randomization to 2 cycles of induction before consolidation therapy（100 days）, and test Every 3 months during follow-up
CR1 bridge-to-allo-HSCT rate
Tidsramme: Up to 6 months after enrollment
Proportion of subjects who achieve CR/CRi and successfully receive allo-HSCT within 2-3 cycles
Up to 6 months after enrollment
Overall Survival (OS)
Tidsramme: From the time from randomization to time for up to 2 years
Time from C1D1 to death from any cause; data censored at last follow-up for surviving subjects
From the time from randomization to time for up to 2 years
Event-Free Survival (EFS)
Tidsramme: From the time from randomization to time for up to 2 years
Time from C1D1 to first event (no CRc after 2 cycles, morphological/extramedullary relapse, disease progression, off-protocol anti-leukemia therapy, death from any cause); data censored at last follow-up for event-free subjects
From the time from randomization to time for up to 2 years
Relapse-Free Survival (RFS)
Tidsramme: From the time from randomization to time for up to 2 years
Time from first CR/CRi to relapse or death from any cause; relapse defined as bone marrow blasts ≥5%, extramedullary disease, peripheral blasts, or molecular MRD ≥10-⁴ in previously MRD-negative patients;data censored at last follow-up for relapse-free subjects
From the time from randomization to time for up to 2 years
100-day Non-Relapse Mortality (100-day NRM)
Tidsramme: Up to 100 days after initial MPAL diagnosis
Proportion of deaths from non-relapse causes within 100 days of diagnosis
Up to 100 days after initial MPAL diagnosis
Incidence of grade ≥3 adverse events (AEs)
Tidsramme: From treatment initiation to the end of Induction
Type, frequency and severity of grade ≥3 AEs graded by CTCAE v5.0
From treatment initiation to the end of Induction

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 Principal Investigator

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 (Antatt)

1. mai 2026

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

30. juni 2028

Datoer for studieregistrering

Først innsendt

26. april 2026

Først innsendt som oppfylte QC-kriteriene

1. mai 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MPAL-1

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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