Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia (HEAL)
18. oktober 2019 oppdatert av: Assistance Publique - Hôpitaux de Paris
Characterization of Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia
Hyper-leukocytosis > 50.109/L is observed in 15% of acute myeloid leukemia (AML).
Level of hyper-leukocytosis is linearly associated with the incidence of life threatening complications that lead to the early death in 25% of these patients.
The HEAL project is a prospective, uni-centric, observational study that plans to include a cohort of 50 patients presenting de novo AML with hyper-leukocytosis (HL) (> 50.109/L) and 10 controls. The aim of the study is to describe the relative proportion of various hemostasis components disturbances, endothelium alterations, platelet dysfunction and to calculate cumulative incidence of hemorrhagic and thrombotic complications as well as overall survival of patients presenting with HL AML.
Studieoversikt
Status
Ukjent
Forhold
Studietype
Observasjonsmessig
Registrering (Forventet)
60
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
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients with acute myleoid leukemia associated to hyper-leukocytosis
Beskrivelse
Inclusion Criteria:
- De novo AML
- GB counts > 50 G/L
- Eligible for intensive chemotherapy
- no previous AML treatment
Exclusion Criteria:
- secondary AML
- relapse of AML
- Acute promyelocytic leukemia
- Previous antiplatelet or anticoagulant treatment
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Cases
Patients with acute myeloid leukemia, associated to hyper leukocytosis
|
|
Control
Patients with acute myeloid leukemia, without hyper leukocytosis
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ICAM-
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of ICAM-
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of Syndecan-1
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of Syndecan-1
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of vWF Ag
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of vWF Ag
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by vWF activity
Tidsramme: 12hours after chemotherapy initiation
|
vWF activity
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fg
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of Fg
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of t-PA
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of u-PA
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of u-PA
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of e-Selectin
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of e-Selectin
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of sCD40L
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of sCD40L
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of IL6
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of IL6
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of AT
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of AT
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fragments thrombin 1+2
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of Fragments thrombin 1+2
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of TAT complex
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of TAT complex
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of plasmin-antiplasmin complex
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of plasmin-antiplasmin complex
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 Ag
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of PAI-1 Ag
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 activity
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of PAI-1 activity
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA-PAI-1 complex
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of t-PA-PAI-1 complex
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ADAMTS13 Ag
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of ADAMTS13 Ag
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by ADAMTS13 activity
Tidsramme: 12hours after chemotherapy initiation
|
ADAMTS13 activity
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of vWF:CB
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of vWF:CB
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fibrin monomers
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of Fibrin monomers
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by Prothrombine Time
Tidsramme: 12hours after chemotherapy initiation
|
Prothrombine Time
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by Activated Partial Thromboplastin Time [APTT]
Tidsramme: 12hours after chemotherapy initiation
|
Activated Partial Thromboplastin Time [APTT]
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor IX
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of Factor IX
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor II
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of Factor II
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor VIII
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of Factor VIII
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor XII
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of Factor XII
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor X
Tidsramme: 12hours after chemotherapy initiation
|
plasma concentration of Factor X
|
12hours after chemotherapy initiation
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cumulative incidence of serious bleeding events
Tidsramme: 1 month
|
Time from inclusion to first serious bleeding event
|
1 month
|
|
Cumulative incidence of thrombotic events
Tidsramme: 1 month
|
Time from inclusion to first thrombotic event
|
1 month
|
|
Overall survival
Tidsramme: 1 month
|
Time from inclusion to death of any cause
|
1 month
|
|
ICU length of stay
Tidsramme: 1 month
|
duration of stay in ICU within the first month
|
1 month
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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 (Forventet)
1. oktober 2019
Primær fullføring (Forventet)
1. februar 2022
Studiet fullført (Forventet)
1. juli 2022
Datoer for studieregistrering
Først innsendt
1. juli 2019
Først innsendt som oppfylte QC-kriteriene
18. oktober 2019
Først lagt ut (Faktiske)
21. oktober 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. oktober 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. oktober 2019
Sist bekreftet
1. juni 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 190002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Leukemi, Myeloid, Akutt
-
University of PennsylvaniaAktiv, ikke rekrutterendeAkutt myeloid leukemi, i tilbakefall | Akutt myeloid leukemi, refraktær | Akutt myeloid leukemi, pediatriskForente stater
-
Betta Pharmaceuticals Co., Ltd.Har ikke rekruttert ennåAkutt Myeloid Leukemi LeukemiKina
-
Washington University School of MedicineTilbaketrukketRefraktær Akutt Myeloid Leukemi | Tilbakefallende akutt myeloid leukemiForente stater
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.AvsluttetAkutt myeloid leukemi | Refraktær Akutt Myeloid Leukemi | Tilbakefallende akutt myeloid leukemiForente stater
-
Peking University People's HospitalBeijing JD Biotech Co. LTD.RekrutteringAkutt myeloid leukemi, i tilbakefall | Akutt myeloid leukemi refraktærKina
-
Xuzhou Medical UniversityRekrutteringAkutt myeloid leukemi, i tilbakefall | Akutt myeloid leukemi refraktærKina
-
Bio-Path Holdings, Inc.RekrutteringAkutt myeloid leukemi, i tilbakefall | Akutt myeloid leukemi refraktærForente stater
-
Xuzhou Medical UniversityRekrutteringAkutt myeloid leukemi, i tilbakefall | Akutt myeloid leukemi refraktærKina
-
Children's Oncology GroupNational Cancer Institute (NCI)FullførtBarndom Akutt Myeloid Leukemi/Andre Myeloid MaligniteterForente stater
-
Ascentage Pharma Group Inc.Suzhou Yasheng Pharmaceutical Co., Ltd.RekrutteringStudie av APG2575 enkeltmiddel og kombinasjon med terapi hos pasienter med tilbakefall/refraktær AMLMyeloid malignitet | Tilbakefallende/Refraktær Akutt Myeloid LeukemiKina