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Donor Immune Cell Therapy for Acute Myeloid Leukemia

17. april 2022 opdateret af: First Affiliated Hospital Xi'an Jiaotong University

Trial of Donor Immune Cell Therapy for Acute Myeloid Leukemia.

This study aims to introduce a new technology of donor NK cell infusion. NK cells defend against viruses and cancer cells in vivo whereas this effect declines in patiens with tumors. In this study, NK cells will be separated from donated peripheral blood or umbilical cord blood. Eligible NK cells will be infused to patients with Acute myeloid leukemia (AML). This new therapy will probably induce their sustained remission and reduce recurrences.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Primary end point:

To determine the rate of overall survival at 2 years of Interventional cohort

Secondary end point:

To determine the cumulative incidence of relapse at 2 years. To determine the rate of disease-free survival at 2 years. Describe the safety and toxicity of donor NK cell infusion.

Study Design:

This study is a phase I clinical trial. 15 eligible AML patients will be enrolled sequentially to receive detached NK cells product during induction or consolidation therapy. Refractory or relapsed patients and patients who achieved complete remission (CR) after induction therapy are included. They will receive anthracycline-based chemotherapy according to NCCN guidelines. At the same time, Cultured NK cells will be infused into patients after chemotherapy. Anti-allergic therapy and prophylaxis of graft versus host disease (GVHD) will be given before infusion. Treatment effect will be measured and adverse effect will be treated and documented after intervention.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

15

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: huaiyu Wang, doctor
  • Telefonnummer: 0086-18991232410
  • E-mail: whymed@126.com

Undersøgelse Kontakt Backup

  • Navn: sha Gong, doctor
  • Telefonnummer: 0086-18710720955
  • E-mail: 314621649@qq.com

Studiesteder

  • Kina
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710016
        • Rekruttering
        • First Affiliated Hospital of Xian Jiaotong University
        • Kontakt:
          • Huaiyu Wang, Doctor
          • Telefonnummer: 0086-15809207527
          • E-mail: whymed@126.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients must have been diagnosed as acute myeloid leukemia in accordance with "Chinese Diagnosis and Treatment Guidelines of AML". Those who achieved CR after chemotherapy are mainly included. Refractory/relapsed AML can also be enrolled.
  • Patients with normal heart function (ejection fraction ≥ 50%), normal liver function(ALT and AST ≤ 2.5 times the upper limit of normal value, bilirubin ≤ 2 times the upper limit of normal value) and normal renal function with blood creatinine ≤ 3.0 mg/dL (≤ 260 µmol /L) can be enrolled.
  • Patients will be required to sign an informed consent.

Exclusion Criteria:

  • Patients with severe infection or other malignant tumors.
  • Women during pregnancy or lactation.
  • Other patients deemed unsuitable by the investigator.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: immune cell arm
Umbilical cord blood or donated peripheral blood of healthy donors were collected and NK cells were cultured. NK cell production will be infused after chemotherapy.
Biologisk: infusion of natural killer cells
Umbilical cord blood or donated peripheral blood of healthy donors were collected and NK cells were sorted and cultured. NK cell production will be infused after chemotherapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
hematological response rate
Tidsramme: up to 2 years, from treatment begining to death
Hematological Complete Remission (HCR): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x10^9/L; platelet count >100x10^9/L.
up to 2 years, from treatment begining to death
Overall survival
Tidsramme: Up to 2 years after beginning treatment
Overall survival (OS) is measured from the date of first infusion of NK cells to the date of death from any cause; patients not known to have died at last follow up are censored on the date they were last known to be alive.
Up to 2 years after beginning treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cumulative incidence of relapse
Tidsramme: Up to 2 years after beginning treatment
Relapse was defined as the recurrence of above 5%bone marrow blasts and the reappearance of blasts in the blood or the development of extramedullary disease infiltrates at any site.
Up to 2 years after beginning treatment
Disease free survival (DFS)
Tidsramme: Up to 2 years after beginning treatment
Disease free survival (DFS) is defined as the time from the date of first infusion of NK cells to the date of relapse or death as a result of any cause.
Up to 2 years after beginning treatment
Incidence of adverse effects
Tidsramme: Up to 2 years after beginning treatment
Toxic effects were graded according to the National Cancer Institute's Common Toxicity Criteria.
Up to 2 years after beginning treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Efterforskere

  • Studiestol: huaiyu Wang, doctor, First Affiliated Hospital Xi'an Jiaotong University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2021

Primær færdiggørelse (Forventet)

1. juli 2024

Studieafslutning (Forventet)

1. september 2024

Datoer for studieregistrering

Først indsendt

23. marts 2022

Først indsendt, der opfyldte QC-kriterier

17. april 2022

Først opslået (Faktiske)

19. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. april 2022

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • XJYFY-2020N8

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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