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Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients

12. november 2019 opdateret af: Fred Hutchinson Cancer Center

Feasibility and Outcomes of Allogeneic Hematopoietic Cell Transplantation (HCT) Compared to Conventional Therapy for Older and Medically Infirm Patients Diagnosed With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes: A Prospective Observational Study

The purpose of this study is to compare treatment methods and outcomes of patients diagnosed with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is a prospective multicenter observational study in a Consortium of collaborating institutions investigating how often older and medically infirm patients who are diagnosed with Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndromes (MDS) and treated with induction chemotherapy undergo allogeneic HCT. Investigators will look at the rate of undergoing allogeneic HCT among older and medically infirm AML and high-risk MDS patients compared to younger and relatively healthier patients. Investigators will also compare the characteristics and outcomes of patients who did versus did not proceed to allogeneic HCT. A number of outcomes will be assessed including mortality, morbidity, and quality of life (QOL). Baseline information will be collected on different domains of QOL, geriatric assessment, health status measures, AML features, and socioeconomic status. Information will help physicians and patients to decide on best treatment choices for AML and high-risk MDS in older and medically infirm patients.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

703

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Stanford, California, Forenede Stater, 94305
        • Stanford Cancer Institute
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Memorial Hospital
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • The John Theurer Cancer Center at Hackensack University Medical Center
    • New York
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania Abramson Cancer Center
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • University of Utah Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Forenede Stater, 98109
        • SCCA Network Clinics

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will include non-M3 AML (including first relapsed and primary refractory AML) and high-risk MDS, MPN, and MF adult patients considered for chemotherapy at FHCRC and the Seattle Cancer Care Alliance Network and other Core institutions (Stanford School of Medicine, Cleveland Clinic, Northwestern University, University of Utah, University of Pennsylvania, Washington University in St. Louis, Roswell Park Cancer Institute, Hackensack University, University of Maryland, and Duke University).

Beskrivelse

Inclusion Criteria

Patients with new diagnoses of non-M3 AML or high-risk MDS, myeloproliferative neoplasms (MPN), or myelofibrosis (MF) (showing 10% or more blasts in bone marrow) who:

  • Present for an AML-like treatment that could plausibly produce a complete remission (CR); for example intensive induction chemotherapy, low dose single agent chemotherapy, hypomethylation agent, or a similar therapy
  • Possibility to retrieve follow-up records from the collaborating institution or treating primary care physician
  • Patients with primary refractory or first relapse presenting for salvage chemotherapy will be allowed
  • Patients of 18 years of age or older, and are being treated by the adult AML service.
  • Able to speak and read English.
  • Willing and able to provide informed consent.

Exclusion Criteria

  • Patients of ≤17 years of age or who are 18 or older and receive treatment under the pediatric AML service.
  • Patients older than 80 years
  • Patients with <6 months projected survival due to active second malignancy or other medical problem.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)
Tidsramme: 1 year after starting induction
Percentage analyzed participants receiving HCT
1 year after starting induction

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage Analyzed Participants Without HCT and Deceased
Tidsramme: 1 year after starting induction
Percentage analyzed participants without HCT and Deceased
1 year after starting induction

Samarbejdspartnere og efterforskere

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

Sponsor

Fred Hutchinson Cancer Center

Samarbejdspartnere

Patient-Centered Outcomes Research Institute
American Cancer Society, Inc.

Efterforskere

  • Ledende efterforsker: Mohamed Sorror, MD, MSc, Associate Member, Fred Hutch; Associate Professor of Medicine, UW

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)

19. juli 2013

Primær færdiggørelse (Faktiske)

4. december 2018

Studieafslutning (Faktiske)

4. december 2018

Datoer for studieregistrering

Først indsendt

14. august 2013

Først indsendt, der opfyldte QC-kriterier

21. august 2013

Først opslået (Skøn)

28. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2368.00
  • RSG-13-084-01-CPHPS (Andet bevillings-/finansieringsnummer: American Cancer Society)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Akut myeloid leukæmi (AML)

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs in Mali

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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