Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Allogeneic Hematopoietic Stem Cell Transplantation (RICE)

18. januar 2011 opdateret af: University Hospital, Clermont-Ferrand

Feasibility Study on Allogeneic Hematopoietic Stem Cell Transplantation Following Fludarabine-Busulfan-ALS-based Reduced-intensity Conditioning in Children With Hematological Malignancy or Solid Tumor Not Responding to Standard Therapy or for Which the Indication for Allograft is Maintained But Cannot be Carried Out Due to the Toxicity Involved in Myeloablative Conditioning.

To assess the engraftment of hematopoietic stem cells following reduced-intensity conditioning in children presenting with solid tumors or hematological malignancy by evaluating post-transplantation chimerism and hematological reconstitution.

To study acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post-transplantation To study the effectiveness of the protocol on tumor response.

To study overall survival.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Medicin: Fludarabine, Busulfan, Thymoglobulin

Detaljeret beskrivelse

Primary criterion

Hematological reconstitution and chimerism post-transplantation

Secondary criteria

Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions
Analysis of variations in post-transplantation immunological function profiles
Median duration of response in therapy-responsive patients and median duration of stability in stabilized patients

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

Fase

Fase 2

Kontakter og lokationer

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

Studiesteder

Frankrig
- - Clermont-Ferrand, Frankrig, 63003
    - Rekruttering
    - Paillard Catherine
    - Kontakt:
      
      Paillard Catherine, Dr
      
      E-mail: cpaillard@chu-clermontferrand.fr

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

Ikke ældre end 20 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Patients aged less than 20 years old
Lansky score > 60%
Life expectancy greater than 2 months
Diagnoses:
3- Solid tumor or hematological malignancy remaining unresponsive to the reference strategies according to French best practices in pediatrics.
4- Malignancies for which allografting is the recognized indication but is contraindicated with myeloablative conditioning.
Usual criteria for allogeneic grafting (pre-graft profile)
Having a HLA-identical sibling donor for HLA-A, HLA-B and HLA-DR antigens or a HLA mismatch on only one antigen, or having a 10/10 pheno-identical donor, or compatible cord blood.
Signed informed consent

Exclusion Criteria:

Patient presenting rapidly-progressive malignancy
In cases where the potential donor is related, sibling presenting contraindication against hematopoietic stem cell donation
Unable to sufficiently understand the treatment and its consequences, even after explanation

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Primary criterion - Hematological reconstitution and chimerism post-transplantation Tidsramme: post-transplantation	post-transplantation

Sekundære resultatmål

Resultatmål	Tidsramme
Secondary criteria - Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions Tidsramme: post-transplantation	post-transplantation

Samarbejdspartnere og efterforskere

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

Sponsor

University Hospital, Clermont-Ferrand

Efterforskere

Ledende efterforsker: Paillard Catherine, Dr, University Hospital, Clermont-Ferrand

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. april 2007

Primær færdiggørelse (Forventet)

1. april 2009

Studieafslutning (Forventet)

1. april 2009

Datoer for studieregistrering

Først indsendt

9. september 2008

Først indsendt, der opfyldte QC-kriterier