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Safety of Allogeneic Hematopoietic Cell Transplantation (HCT) For Patients With Classical Hodgkin Lymphoma (CHL) Treated With Nivolumab

14. marts 2022 opdateret af: Bristol-Myers Squibb

Observational Cohort Study to Characterize the Safety of Allogeneic Hematopoietic Cell Transplantation (HCT) For Patients With Classical Hodgkin Lymphoma (CHL) Treated With Nivolumab

An observational database analysis, using existing data of patients diagnosed with Classical Hodgkin Lymphoma.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study will include a retrospective and prospective observational database analysis.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

95

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • New Jersey
      • Princeton, New Jersey, Forenede Stater, 08540
        • Bristol-Myers Squibb
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Center for International Blood and Marrow Transplant Research

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study will target enrollment of 90 patients who were treated with nivolumab-based regimen prior to an allogeneic HCT with at least 45 patients who received nivolumab immediately prior to the allogeneic HCT

Beskrivelse

Inclusion Criteria:

  • Age greater than or equal to18 years;
  • First allogeneic HCT for cHL;
  • Patients with prior autologous HCT for cHL;
  • Any conditioning regimen, graft source or donor type.
  • For the primary analysis additional criterion includes prior exposure to nivolumab for treatment of cHL immediately prior to the allogeneic HCT, as defined as nivolumab used alone or in combination with other agents and used as the last line of therapy prior to an allogeneic HCT with the interval between the last dose of nivolumab and start of the conditioning regimen no longer than 12 months.

Exclusion Criteria:

  • Patients with nodular lymphocyte-predominant HL
  • Previous chimeric antigen receptor T-cell therapy or other genetically modified cellular product

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Exposed to nivolumab prior to allogeneic HCT
patients who were treated with nivolumab-based regimen prior to an allogeneic HCT
Andet: Ikke-interventionel
Ikke-interventionel
Unexposed to nivolumab prior to allogeneic HCT
patients who were not treated with nivolumab-based regimen prior to an allogeneic HCT
Andet: Ikke-interventionel
Ikke-interventionel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment-Related Mortality (TRM)
Tidsramme: At 6 months after an allogeneic HCT
Treatment-Related Mortality at 6 months after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab
At 6 months after an allogeneic HCT

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of disease progression
Tidsramme: Up to 2 years
Measured by clinical assessment
Up to 2 years
Incidence of acute Graft Versus Host Disease (GVHD)
Tidsramme: Up to 2 years
Either Grade II-IV or Grade III-IV acute GVHD. Measured by clinical assessment
Up to 2 years
Incidence of chronic Graft Versus Host Disease (GVHD)
Tidsramme: Up to 2 years
Measured by clinical assessment
Up to 2 years
Incidence of post-transplant sinusoidal obstruction syndrome (SOS)
Tidsramme: Up to 2 years
Measured by clinical assessment
Up to 2 years
Incidence of post-transplant interstitial pneumonitis (IPN)
Tidsramme: Up to 2 years
Measured by clinical assessment
Up to 2 years
Incidence of post-transplant renal toxicity requiring dialysis
Tidsramme: Up to 2 years
Measured by clinical assessment
Up to 2 years
Overall Survival (OS)
Tidsramme: Up to 2 years
OS is measured from the date of allogeneic transplant to death.
Up to 2 years
Progression-Free Survival (PFS)
Tidsramme: Up to 2 years
PFS is measured from the date of allogeneic transplant to the date of disease progression or death.
Up to 2 years
TRM at 100 days
Tidsramme: At 100 days after an allogeneic HCT
Treatment-Related Mortality at 100 days after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab
At 100 days after an allogeneic HCT
TRM at 1 year
Tidsramme: At 1 year after an allogeneic HCT
Treatment-Related Mortality at 1 year after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab
At 1 year after an allogeneic HCT
TRM at 2 years
Tidsramme: At 2 years after an allogeneic HCT
Treatment-Related Mortality at 2 years after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab
At 2 years after an allogeneic HCT

Samarbejdspartnere og efterforskere

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

Sponsor

Bristol-Myers Squibb

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.

Hjælpsomme links

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)

14. juni 2016

Primær færdiggørelse (Forventet)

1. juni 2022

Studieafslutning (Forventet)

30. december 2022

Datoer for studieregistrering

Først indsendt

26. juni 2017

Først indsendt, der opfyldte QC-kriterier

26. juni 2017

Først opslået (Faktiske)

27. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CA209-835

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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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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