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Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation

18. juli 2017 opdateret af: Marco Mielcarek, Fred Hutchinson Cancer Center

Donor Statin Treatment for Prevention of Severe Acute GVHD After Myeloablative Hematopoietic Cell Transplantation

This phase II trial studies donor atorvastatin treatment for the prevention of severe acute graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the patient's immune system reject the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving atorvastatin to the donor before transplant may prevent this from happening.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute GVHD.

SECONDARY OBJECTIVES:

I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible, tolerable and safe.

OUTLINE:

Donors receive atorvastatin orally (PO) beginning on day -14 and continuing until the last day of stem cell collection.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

83

Fase

  • Fase 2

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 University Hospitals and Clinics
    • Colorado
      • Denver, Colorado, Forenede Stater, 80907
        • Colorado Blood Cancer Institute
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Human leukocyte antigen (HLA)-identical sibling donor
  • Myeloablative preparative regimen (i.e., >= TBI 12.0 Gy, >= busulfan (BU) 8.0 mg/kg PO, >= BU 6.4 mg/kg intravenously (IV), >= treosulfan 42 g/m^2 IV) according to investigational study or standard treatment plan; other "myeloablative" preparative regimens are acceptable as long as they are approved by the principal investigator or designee
  • Transplantation of PBSC
  • Cyclosporine (CSP)-based postgrafting immunosuppression
  • Willingness to give informed consent
  • DONOR: Age >= 18 years
  • DONOR: HLA genotypically identical sibling
  • DONOR: Willingness to give informed consent

Exclusion Criteria:

  • Nonmyeloablative preparative regimen
  • Participation in an investigational study that has acute GVHD as the primary endpoint
  • The allogeneic PBSC donor has a contraindication to statin treatment
  • DONOR: Age < 18 years
  • DONOR: Active liver disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels > 2 times the upper limit of normal [ULN])
  • DONOR: History of myopathy
  • DONOR: Hypersensitivity to atorvastatin
  • DONOR: Pregnancy
  • DONOR: Nursing mother
  • DONOR: Current serious systemic illness
  • DONOR: Concurrent treatment with strong inhibitors of hepatic cytochrome P450 (CYP) 3A4 (i.e. clarithromycin, erythromycin, protease inhibitors, azole antifungals)
  • DONOR: Current use of statin drug
  • DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) or local criteria for stem cell donation
  • DONOR: Total creatinine kinase > 2 times the ULN

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Supportive care (donor statin treatment)
Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.
Medicin: Atorvastatin Calcium
Givet PO
Andre navne:
  • Lipitor
  • CI-981
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo myeloablative allogeneic PBSC transplant
Andre navne:
  • HSC
  • HSCT
  • allogen stamcelletransplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Undergo myeloablative allogeneic PBSC transplant
Andre navne:
  • PBPC transplantation
  • Perifer blodprogenitorcelletransplantation
  • Perifer stamcellestøtte
  • Perifer stamcelletransplantation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Grade 3-4 Acute GVHD
Tidsramme: First 100 days after transplant
Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients.
First 100 days after transplant

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Chronic Extensive GVHD
Tidsramme: 2 years post transplant
Cumulative incidence rate of chronic extensive GVHD with death as a competing risk, assessed at 2 years in the patients/recipients.
2 years post transplant
Disease-free Survival
Tidsramme: 1 year after transplant
Evaluated as Kaplan-Meier estimate in the patients/recipients.
1 year after transplant
Grades II-IV Acute GVHD
Tidsramme: First 100 days after transplant
Cumulative incidence rate of grades II-IV acute GVHD with death as a competing risk, assessed at 100 days in the patients/recipients.
First 100 days after transplant
Non-relapse Mortality
Tidsramme: At day 100
Cumulative incidence rate of non-relapse mortalities, assessed at day 100 in the patients/recipients.
At day 100
Non-relapse Mortality
Tidsramme: At 1 year after HCT
Cumulative incidence rate of non-relapse mortalities, assessed at one year in the patients/recipients.
At 1 year after HCT
Overall Survival
Tidsramme: 1 year after transplant
Determined and presented as Kaplan-Meier estimates, assessed at 1 year in the patients/recipients.
1 year after transplant
Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity
Tidsramme: Until completion of stem cell collection (on average 14 days)
Until completion of stem cell collection (on average 14 days)
Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy
Tidsramme: First 100 days after transplant
First 100 days after transplant
Recurrent or Progressive Malignancy
Tidsramme: Up to 3 years
Cumulative incidence rate of recurrent or progressive malignancy with death as a competing risk, assessed at 3 years in the patients/recipients.
Up to 3 years

Samarbejdspartnere og efterforskere

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

Sponsor

Fred Hutchinson Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)

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

1. maj 2012

Primær færdiggørelse (Faktiske)

1. september 2015

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

31. januar 2012

Først indsendt, der opfyldte QC-kriterier

2. februar 2012

Først opslået (Skøn)

3. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2545.00 (Anden identifikator: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
  • P30CA015704 (U.S. NIH-bevilling/kontrakt)
  • NCI-2011-03827 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01HL108307 (U.S. NIH-bevilling/kontrakt)

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 .

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