Etude : ATG-CyGVHD / P150955



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : ATG-CyGVHD

Nom : P150955

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 27/09/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Cyclophosphamide Versus Anti-thymocyte Globulin for GVHD Prophylaxis After RIC Allo-SCT

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C96 - Tumeurs malignes des tissus lymphoïde, hématopoïétique et apparentés, autres et non précisées
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The study is designed as a two arm randomized Phase II, multicenter trial comparing cyclophosphamide to anti-thymocyte globulin for Graft-versus-Host Disease (GVHD) prophylaxis in patients with hematologic malignancies undergoing reduced intensity conditioning hematopoietic stem cell transplantation.

Study arms:
- Experimental: Cyclophosphamide
50mg/Kg/day cyclophosphamide (day +3 and +4)
Interventions:
Drug: Cyclophosphamide
Drug: Conditioning regimen
- Active Comparator: Anti-Thymocyte Globulin
2.5 mg/Kg/day ATG (Thymoglobuline®) for 2 consecutive days (day -2 and -1)
Interventions:
Drug: Anti-Thymocyte Globulin
Drug: Conditioning regimen

Intervention:
- Drug: Cyclophosphamide
GVHD prophylaxis: All patients will receive post-transplant 50mg/Kg/day cyclophosphamide (day +3 and +4) AND cyclosporine-A alone in case of an HLA-sibling donor, or cyclosporine-A and mycophenolate-mofetil in case of an HLA-matched unrelated donor
Other Name: Cyclophosphamide + cyclosporine-A +/-mycophenolate-mofetil
- Drug: Anti-Thymocyte Globulin
GVHD prophylaxis: 2.5 mg/Kg/day ATG (Thymoglobuline®) for 2 consecutive days (day -2 and -1) All patients will receive cyclosporine-A alone in case of an HLA-sibling donor, or cyclosporine-A and mycophenolate-mofetil (MMF) in case of an HLA-matched unrelated donor.
Other Name: Anti-Thymocyte Globulin + cyclosporine-A +/-mycophenolate-mofetil
- Drug: Conditioning regimen
30 mg/m2/day fludarabine for 5 days (day-6 to day-2) 130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3)

Phase : II

Stade : NA

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patients aged between 18 and 65 years
- Presence of a hematologic malignancy for which a reduced-intensity conditioning allo-SCT is indicated (eligibility criteria for RIC allo-SCT include at least one of the following parameters: (i) patient age older than 50 years; (ii) heavily pre-treated patients who received an autologous hematopoietic SCT (auto-SCT) or with more than 2 lines of chemotherapy before allo-SCT; and (iii) patients with poor performance status because of significant medical comorbidities as described by Sorror et al.
- Karnofsky index ≥ 70%
- Availability of a sibling or unrelated stem-cell donor (10/10-HLA matched unrelated donor)
- Efficient contraceptive method within 1 month for women and 3 months for men after the last dose of treatment
- Written informed consent.

Critères de non-inclusion : - Creatinine clearance less than 30 mL/min
- Bilirubin or amino-transferases above 3X upper normal limit
- Cardiac ejection fraction less than 40%
- Pulmonary impairment with <50% lung carbon monoxide diffusing capacity (DLCO)
- Known hypersensitivity or contraindication to the use of post-transplant Cy and ATG
- Any circumstance that precludes the use of the drugs involved in the protocol
- Pregnancy
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02876679
Promoteur :
APHP
Type de sponsor : Institutionnel
75010 PARIS 10

Coordonnateur :
Professeur Mohamad MOHTY
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Henri Becquerel - Rue d'Amiens CS 11516 - Cedex 1 - 76000 ROUEN

Investigateur :
Anne-Lise MENARD

TEC / ARC / IDE :
stéphanie SERIS
stephanie.seris@
chb.unicancer.fr
02.32.08.24.98

Ouverture de l'essai : OUVERT

MAJ : 27/09/2019