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Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation

5. oktober 2015 oppdatert av: Kiadis Pharma

An Observational Cohort Study on Transplant-Related Mortality in Patients Receiving Either a Hematopoietic Stem Cell Transplantation Without ATIR or an Umbilical Cord Blood Transplantation

Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

178

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Belgia
- - Brugge, Belgia, 8000
    - Algemeen Ziekenhuis Sint-Jan
  - Brussels, Belgia, 1000
    - Institut Jules Bordet
  - Leuven, Belgia, 3000
    - Universitair Ziekenhuis Gasthuisberg
Canada
- Ontario
  - Hamilton, Ontario, Canada, L8N 3Z5
    - Hamilton Niagara Regional Haemophilia Centre
- Quebec
  - Montreal, Quebec, Canada, H1T 2M4
    - Maisonneuve-Rosemont Hospital
Forente stater
- Ohio
  - Columbus, Ohio, Forente stater, 43210
    - Ohio State University Comprehensive Cancer Center
Nederland
- - Maastricht, Nederland, 6229 HX
    - Academisch Ziekenhuis Maastricht
Storbritannia
- - London, Storbritannia, W12 OHS
    - Hammersmith Hospital
Tyskland
- - Würzburg, Tyskland, 97080
    - Universitätsklinikum Würzburg

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

Sannsynlighetsprøve

Studiepopulasjon

Patients having received a haploidentical hematopoietic stem cell transplantation (HSCT) between 1 January 2006 and 30 June 2014, an HSCT from an unrelated donor between 1 January 2010 and 31 December 2012, or a double UCB transplantation between 1 January 2010 and 31 December 2012 will be selected from the centers that enrolled patients in study CR-AIR-004 and/or study CR-AIR-007.

Beskrivelse

Inclusion Criteria:

Any of the following hematologic malignancies:
- Acute myeloid leukemia (AML) in remission at the time of the transplantation
- Acute lymphoblastic leukemia (ALL) in remission at the time of the transplantation
- Myelodysplastic syndrome (MDS)
Patient received any of the following transplantations:
- Allogeneic T-cell depleted HSCT without ATIR administration from a haploidentical donor between 1 January 2006 and 30 June 2013 (HAPLO group)
- Allogeneic HSCT from a fully matched or 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012 (MUD/MMUD groups)
- Double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012 with no more than 2 human leukocyte antigen (HLA)-mismatches at HLA-A, B, and/or -DR between each of the units and the recipient (UCB group)
Male or female, age ≥ 18, ≤ 65 years.

Exclusion Criteria:

Allogeneic stem cell transplantation prior to the transplantation qualifying for the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
HAPLO group Control group of all eligible patients who received an HSCT from a haploidentical donor without ATIR administration between 1 January 2006 and 30 June 2013
MUD group Control group of eligible patients who received an HSCT from a fully matched unrelated donor between 1 January 2010 and 31 December 2012
MMUD group Control group of eligible patients who received an HSCT from a 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012
UCB group Control group of eligible patients who received a double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Transplant-related mortality Tidsramme: Up to 12 months after the transplantation	Up to 12 months after the transplantation

Sekundære resultatmål

Resultatmål	Tidsramme
Overall survival Tidsramme: Up to 12 months after the transplantation	Up to 12 months after the transplantation
Incidence of acute and chronic graft versus host disease Tidsramme: Up to 12 months after the transplantation	Up to 12 months after the transplantation
Progression-free survival Tidsramme: Up to 12 months after the transplantation	Up to 12 months after the transplantation
Severity of acute and chronic graft versus host disease Tidsramme: Up to 12 months after the transplantation	Up to 12 months after the transplantation
Relapse-related mortality Tidsramme: Up to 12 months after the transplantation	Up to 12 months after the transplantation

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kiadis Pharma

Etterforskere

Studiestol: Jeroen Rovers, MD, Kiadis Pharma

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

1. september 2014

Primær fullføring (Faktiske)

1. juni 2015

Studiet fullført (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først innsendt

10. juli 2014

Først innsendt som oppfylte QC-kriteriene