Etude : JZP963-201 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : JZP963-201

Nom :

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 28/05/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Phase 2, Prospective, Randomized, Open-Label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopietic Stem Cell Transplant

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C95 - Leucémie à cellules non précisées

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C88 - Maladies immunoprolifératives malignes
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Study arms:
- Experimental: Defibrotide Prophylaxis
Standard of Care Immunoprophylaxis + Defibrotide
Interventions:
Drug: Defibrotide
Drug: Standard of Care
- Active Comparator: Standard of Care
Standard of Care Immunoprophylaxis Alone
Intervention: Drug: Standard of Care

Intervention:
- Drug: Defibrotide
6.25 mg/kg via 2-hour IV infusion every 6 hours
- Drug: Standard of Care
Administered according to local institutional guidelines, physician preference, and patient need.

Current primary outcome:
Cumulative Incidence of Grade B-D aGvHD by Day +100 post-allogeneic HSCT [ Time Frame: 100 Days post-HSCT ]

Current secondary outcomes:
- Grade B-D aGvHD-free survival by Days +100 and +180 post-HSCT [ Time Frame: 180 Days post-HSCT ]
- Cumulative Incidence of Grade B-D aGvHD by Day +180 post-HSCT [ Time Frame: 180 Days post-HSCT ]
- Cumulative Incidence of Grade C-D aGvHD by Days +100 and +180 post-HSCT [ Time Frame: 180 Days post-HSCT ]
- Cumulative Incidence of Relapse by Days +100 and +180 post-HSCT [ Time Frame: 180 Days post-HSCT ]
- Incidence of Systemic Steroid Use in the Treatment of aGvHD by Day +180 post-HSCT [ Time Frame: 180 Days post-HSCT ]
- Health-related Quality of Life (HRQoL) as Measured by Functional Assessment of Cancer Therapy-Bone Marrow Transplant-Trial Outcomes Index (FACT-BMT-TOI) [ Time Frame: 180 Days post-HSCT ]
- HRQoL as Measured by EuroQOL-5D (EQ-5D) [ Time Frame: 180 Days post-HSCT ]

Phase : II

Stade : NA

NA
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patient must be ≥1 year and <75 years of age at screening and undergoing allogeneic HSCT.
- Patient must be diagnosed with acute leukemia in morphologic complete remission (CR1 or CR2) or with MDS with no circulating blasts and with less than 5% blasts in the bone marrow
- Patient must have planned to receive either a myeloablative or reduced-intensity conditioning regimen and have an unrelated donor who is HLA matched or single-allele mismatched
- Patient must receive the following medical regimen as part of standard of care immunoprophylaxis for GvHD in either study arm at doses and regimen determined by local institutional guidelines, physician preference, and patient need:
MTX or MMF + calcineurin inhibitor (CSA or TAC) +/- ATG (ATG use is limited to 30% of patients).
- Graft must be a CD3+ T-cell replete PBSC graft or non-manipulated BM graft.
- Adult patients must be able to understand and sign a written informed consent. For pediatric patients, the parent/legal guardian or representative must be able to understand and sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Critères de non-inclusion : - Patient has had a prior autologous or allogeneic HSCT.
- Patient is using or plans to use an investigational agent for the prevention of GvHD.
- Patient is receiving or plans to receive other investigational therapy and/or is enrolled or plans to enroll in a separate clinical study.
- Patient, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- Patient has a psychiatric illness that would prevent the patient or legal guardian or representative from giving informed consent and/or assent.
- Patient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study.
- Patient is pregnant or lactating and does not agree to stop breastfeeding.
- Any other condition that would cause a risk to the patient if he/she participated in the trial.
- Patient has a known history of hypersensitivity to defibrotide or any of the excipients.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03339297
Promoteur :
JAZZ Pharmaceuticals
Type de sponsor : Industriel
Waterloo Exchange, Waterloo Road, Dublin 4, Ireland
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Ibrahim YAKOUB-AGHA

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Ouverture de l'essai : OUVERT

MAJ : 24/05/2019