Informations générales (source: ClinicalTrials.gov)
Evaluation of a Donor Testing Kit for the Prediction of Acute GVHD in Patient Receiving a Peripheral Blood Stem Cells Allograft- Predictor 2 (Predictor2)
Interventional
Phase 2/Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2019
mars 2023
10 mai 2025
The aim is to validate an in vitro diagnosis medical device to predict grade II to IV
aGVHD after a cell graft
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital La Pitié-Salpêtrière | HERMINE Olivier | 18/04/2025 07:56:15 | Contacter | ||
| AP-HP - Hôpital Necker-Enfants Malades | HERMINE Olivier | 18/04/2025 07:56:15 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HIA PERCY | Jean-Valère MALFUSON, Pr | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Poitiers - 86000 - Poitiers - France | Natacha MAILLARD, Dr | Contact (sur clinicalTrials) | |||
| CHU de Rennes - 35033 - Rennes - France | Marc BERNARD, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Dupuyten - 87042 - Limoges - France | Arnaud JACCARD, Dr | Contact (sur clinicalTrials) | |||
| Institut Universitaire du Cancer de Toulouse - 31059 - Toulouse - France | Anne HUYNH, Dr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU Nancy - Hôpital de Brabois - 54511 - Vandœuvre-lès-Nancy - France | Marie-Thérèse RUBIO | Contact (sur clinicalTrials) | |||
| CHU Amiens-Picardie - 80054 - Amiens - France | Magalie JORIS, Dr | Contact (sur clinicalTrials) | |||
| CHU Angers - 49033 - Angers - France | Sylvie FRANCOIS, Dr | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - 33604 - Pessac - France | Carmen BOTELLA GARCIA, Dr | Contact (sur clinicalTrials) | |||
| CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Lemal RICHARD, Dr | Contact (sur clinicalTrials) | |||
| CHU de Caen - 14033 - Caen - France | Hyacinthe Atchroué JOHNSON-ANSAH, Dr | Contact (sur clinicalTrials) | |||
| CHU Nice - 06002 - Nice - France | Pierre-Simon ROHRLICH, Dr | Contact (sur clinicalTrials) | |||
| Hôpital de la Pitiè-Salpétrière - 75013 - Paris - France | Stéphanie NGUYEN-QUOC, Pr | Contact (sur clinicalTrials) | |||
| Hôtel Dieu - 44035 - Nantes - France | Patrice CHEVALLIER, Dr | Contact (sur clinicalTrials) | |||
| L'Institut de Cancérologie de la Loire - 42270 - Saint-Priest-en-Jarez - France | Emilie CHALAYER, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- PATIENT :
- Age between 18 and 65 years ( included )
- Being candidate to a graft of peripheral hematopoietic stem cells , according
the following criteria :
- HLA compatibility 10 / 10 with the selected donor
- Malignant haematological disorder as described below :
- Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia ( ALL) in 1st or
2d complete remission
- Aggressive lymphoma in complete remission
- Non - progressive myeloproliferative syndrome ,
- Myelodysplasia with stable blasts is cell number and < 10 % of blastocysts,
- Acute leukemia biphenotypic in 1st or 2d complete remission
- Sequential graft conditioning, myeloablative or with a reduced intensity, both may
include ATG
- Classical scheme for immunosuppression decrease ( from day 90 to day 180 ) • Not
being opposed to medical data collection DONOR
- Adult ( ≥ 18 year old) up to the maximum authorized by each National Transplantation
Authority
- Being a patient's sibling or registered in the Bone Marrow Donors Worldwide registry
or a national registry
- Being candidate to a Peripheral Blood Stem Cells donation with a Human Leucocyt
Antigen (HLA) 10 / 10 compatibility with the recipient ,
- Signed and dated informed consent ( in accordance with local regulation of the
country in which the observation is performed )
- PATIENT :
- Age between 18 and 65 years ( included )
- Being candidate to a graft of peripheral hematopoietic stem cells , according
the following criteria :
- HLA compatibility 10 / 10 with the selected donor
- Malignant haematological disorder as described below :
- Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia ( ALL) in 1st or
2d complete remission
- Aggressive lymphoma in complete remission
- Non - progressive myeloproliferative syndrome ,
- Myelodysplasia with stable blasts is cell number and < 10 % of blastocysts,
- Acute leukemia biphenotypic in 1st or 2d complete remission
- Sequential graft conditioning, myeloablative or with a reduced intensity, both may
include ATG
- Classical scheme for immunosuppression decrease ( from day 90 to day 180 ) • Not
being opposed to medical data collection DONOR
- Adult ( ≥ 18 year old) up to the maximum authorized by each National Transplantation
Authority
- Being a patient's sibling or registered in the Bone Marrow Donors Worldwide registry
or a national registry
- Being candidate to a Peripheral Blood Stem Cells donation with a Human Leucocyt
Antigen (HLA) 10 / 10 compatibility with the recipient ,
- Signed and dated informed consent ( in accordance with local regulation of the
country in which the observation is performed )
- Participating in a clinical trial, if interventional on the prophylaxis treatment (
not on the prophylaxis ) of GVHD, in the 30 days prior to the inclusion and during
the Predictor 2 study ,
- Being placed under legal supervision ,
- Presenting any impossibility to fulfil the study requirements, due to geographical,
social or physical reasons