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Confrontare l'efficacia dell'aggiunta di metotrexato (MTX) all'attuale trattamento standard di prima linea con corticosteroidi per la malattia acuta da trapianto contro l'ospite (GVHD) (MTX-aGVHD)

15 settembre 2026 aggiornato da: Assistance Publique - Hôpitaux de Paris

Uno studio multicentrico randomizzato di fase III in doppio cieco che confronta la terapia standard da sola rispetto ai corticosteroidi e il metotrexato a basso dosaggio (MTX) per il trattamento di prima linea della malattia acuta del trapianto contro l'ospite dopo il trapianto di cellule staminali allogeniche

Phase III randomized double-blinded trial designed to compare the efficacy of the addition of MTX to current standard acute GVHD first-line treatment with corticosteroids. The protocol will use a novel endpoint for benchmarking interventions based on a composite primary endpoint of GVHD-free and corticosteroids-free survival.

The primary endpoint of the trial will be the assessment of a composite endpoint of graft-versus-host disease-free and corticosteroids-free survival at 12 months after randomization

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a phase III randomized, multicenter, double blinded controlled study. Patients who develop clinically meaningful acute GVHD and who meet all other entry criteria will be randomized 1:1 to receive either corticosteroids and placebo ("standard of care", control arm) or the combination of low-dose MTX with corticosteroids as first-line therapy for acute GVHD (MTX; "experimental arm").

The primary analysis of this hypothesis generation study is to estimate the composite endpoint of GVHD-free and corticosteroids-free survival at 12 months after randomization in both treatment arms. In fact, it is more and more established that such composite endpoint is a clinically very relevant one because it represents ideal recovery from allo-SCT (Stem Cell transplantation) (at 1 year after acute GVHD diagnosis) and a measure of cure without ongoing morbidity.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

104

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Paris, Francia, 75012
        • Saint Antoine Hospital - Hematology Department

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Adults patients (>=18 years old) with hematological diseases, who develop a first episode of acute GVHD (grade II-IV) requiring systemic therapy
  • First allo-SCT, with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
  • Biopsy of acute GVHD target organ is recommended, but not required. Enrollment should not be delayed awaiting biopsy or pathology results
  • The patient must have received no previous systemic immune suppressive therapy for treatment of acute GVHD, except for a maximum 72 hours of prior corticosteroid therapy
  • Absolute neutrophil count (ANC) greater than 0.5 G/L
  • Platelets count greater than 20 G/L
  • Signed informed consent
  • Affiliation to a social security system (recipient or assign)
  • Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception until 6 months after the end of treatment.

Men with a partner of childbearing potential must agree to use a medically acceptable method of contraception until 6 months after the end of treatment.

Exclusion Criteria:

  • Hyper-acute GVHD as defined by the MD Anderson's criteria (Saliba, de Lima et al. 2007)
  • Flare of GVHD in a patient already on corticosteroid treatment
  • Overlap chronic GVHD as defined by the NIH Consensus Criteria (Jagasia, Greinix et al. 2015)
  • MTX given within 7 days of enrollment
  • Active uncontrolled infection
  • Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
  • Acute GVHD after donor lymphocytes infusion (DLI)
  • Other systemic drugs for GVHD treatment (including extra-corporeal photopheresis)
  • If any prior steroid therapy (for indication other than GVHD), treatment at doses > 0.5 mg/kg/day methyl-prednisolone within 7 days prior to onset of acute GVHD
  • Patients who are pregnant, breast feeding, or if sexually active, unwilling to use effective birth control for the duration of the study
  • Patient on dialysis
  • Patients with veno-occlusive disease of the liver or with significant liver abnormalities who in the judgment of the treating physician cannot receive MTX
  • Patients requiring after inclusion in the protocol the continuation of one or more of the following medication: probenecide, trimethoprime (alone or in combination with sulfametoxazole), phenylbutazone or yellow fever vaccine
  • Patients with a history of intolerance/allergy to MTX
  • Hypersensitivity to the active substance or to any of the excipients

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Methotrexate
  • 3mg/Kg/day methotrexate for 4 weeks then 3 mg/m2 every two weeks for 12 weeks
  • 2mg/kg/day PO prednisone prednisone (or 1.6 mg/kg/day IV methylprednisolone) once daily.
  • 10 mg po or iv lederfolin after each MTX administration
Droga: Methotrexate

Methotrexate 3 mg/m2 will be given once week for 4 weeks, then 3 mg/m2 every two weeks for 12 weeks. Body surface area will be capped at 2 m2.

Methotrexate will be given as an IV infusion over 15 minutes. All patients will received prednisone 2 mg/kg.day PO (or methylprednisolone 1.6 mg/Kg/day) for 3 days.

For responding patients between day 4 and 28, the dose of prednisone must be at least 0.25 mg/kg/day prednisone (or 0.2 mg/kg/day methylprednisolone).

All patients should receive a folinic acid supplementation 24 hours after each MTX/placebo administration.

Lederfoldin 10 mg po or iv will be administered on days 2, 9, 16 and 23. Lederfoldin 10 mg po or iv will be administered on days 37, 51, 65, 79, 93 and 103.
Comparatore placebo: Placebo
  • Once a week placebo for 4 weeks then every two weeks for 12 weeks
  • 2 mg/kg/day PO prednisone (or 1.6 mg/kg/day IV methylprednisolone) once daily.
  • 10 mg po or iv lederfolin after each placebo administration
Droga: Placebo

Placebo 3 mg/m2 will be given once week for 4 weeks, then 3 mg/m2 every two weeks for 12 weeks. Body surface area will be capped at 2 m2.

Placebo will be given as an IV infusion over 15 minutes. All patients will received prednisone 2 mg/kg.day PO (or methylprednisolone 1.6 mg/Kg/day) for 3 days.

For responding patients between day 4 and 28, the dose of prednisone must be at least 0.25 mg/kg/day prednisone (or 0.2 mg/kg/day methylprednisolone).

All patients should receive a folinic acid supplementation 24 hours after each MTX/placebo administration.

Lederfoldin 10 mg po or iv will be administered on days 2, 9, 16 and 23. Lederfoldin 10 mg po or iv will be administered on days 37, 51, 65, 79, 93 and 103.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization.
Lasso di tempo: Evaluation will be performed at time of inclusion

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at time of inclusion
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (1).
Lasso di tempo: Evaluation will be performed before start of MTX at the randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed before start of MTX at the randomization.
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (2).
Lasso di tempo: Evaluation will be performed at Day 8

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 8
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (3).
Lasso di tempo: Evaluation will be performed at Day 15

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 15
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (4).
Lasso di tempo: Evaluation will be performed at Day 22

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 22
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (5).
Lasso di tempo: Evaluation will be performed at Day 28

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 28
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (6).
Lasso di tempo: Evaluation will be performed at Day 36

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 36
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (7).
Lasso di tempo: Evaluation will be performed at Day 50

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 50
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (8).
Lasso di tempo: Evaluation will be performed at Day 56

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 56
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (9).
Lasso di tempo: Evaluation will be performed at Day 64

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 64
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (10)
Lasso di tempo: Evaluation will be performed at Day 78

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 78
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (11).
Lasso di tempo: Evaluation will be performed at Day 92

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 92
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (12).
Lasso di tempo: Evaluation will be performed at Day 102

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 102
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (13).
Lasso di tempo: Evaluation will be performed at 5 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 5 months after randomization.
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (14).
Lasso di tempo: Evaluation will be performed at 6 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 6 months after randomization.
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (17).
Lasso di tempo: Evaluation will be performed at 9 months after randomization .

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 9 months after randomization .
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (18).
Lasso di tempo: Evaluation will be performed at 12 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 12 months after randomization.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (19).
Lasso di tempo: Evaluation will be performed at time of inclusion.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at time of inclusion.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (20).
Lasso di tempo: Evaluation will be performed before start of MTX at the randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed before start of MTX at the randomization.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (21).
Lasso di tempo: Evaluation will be performed at Day 8.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 8.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (20).
Lasso di tempo: Evaluation will be performed at Day 15.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 15.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (21).
Lasso di tempo: Evaluation will be performed at Day 22.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 22.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (22).
Lasso di tempo: Evaluation will be performed at Day 28.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 28.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (23).
Lasso di tempo: Evaluation will be performed at Day 36

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 36
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (24).
Lasso di tempo: Evaluation will be performed at Day 50.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 50.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (25).
Lasso di tempo: Evaluation will be performed at Day 56.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 56.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (26).
Lasso di tempo: Evaluation will be performed at Day 64.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 64.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (27).
Lasso di tempo: Evaluation will be performed at Day 78.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 78.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (28).
Lasso di tempo: Evaluation will be performed at D92.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at D92.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (29).
Lasso di tempo: Evaluation will be performed at Day 102.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 102.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (30).
Lasso di tempo: Evaluation will be performed at 5 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 5 months after randomization.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (31).
Lasso di tempo: Evaluation will be performed at 6 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 6 months after randomization.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (32).
Lasso di tempo: Evaluation will be performed at 9 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 9 months after randomization.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (33).
Lasso di tempo: Evaluation will be performed at 12 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 12 months after randomization.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
L'incidenza di eventi avversi gravi entro i primi 12 mesi dopo la randomizzazione
Lasso di tempo: 12 mesi dopo la randomizzazione
12 mesi dopo la randomizzazione
La percentuale di remissione completa (CR), risposta parziale molto buona (VGPR), risposta parziale (PR), risposta mista (MR), nessuna risposta (NR) e progressione al giorno 28, giorno 56 e migliore risposta entro i primi 12 mesi dopo la randomizzazione.
Lasso di tempo: al giorno 28, giorno 56 e migliore risposta entro i primi 12 mesi dopo la randomizzazione.
al giorno 28, giorno 56 e migliore risposta entro i primi 12 mesi dopo la randomizzazione.
La percentuale di riacutizzazioni di GVHD entro i primi 12 mesi dopo la randomizzazione.
Lasso di tempo: 12 mesi dopo la randomizzazione
12 mesi dopo la randomizzazione
Incidenza cumulativa di GVHD cronica complessiva e grave valutata dai criteri di consenso NIH entro i primi 12 mesi dopo la randomizzazione (Jagasia, Greinix et al. 2015, Lee, Wolff et al. 2015).
Lasso di tempo: entro i primi 12 mesi dopo la randomizzazione
entro i primi 12 mesi dopo la randomizzazione
Incidenza di infezione sistemica e riattivazione di CMV (citomegalovirus) entro 3 mesi dalla randomizzazione
Lasso di tempo: entro 3 mesi dalla randomizzazione
entro 3 mesi dalla randomizzazione
Incidenza della riattivazione dell'EBV (virus di Epstein-Barr) e della malattia linfoproliferativa post-trapianto entro 12 mesi dalla randomizzazione
Lasso di tempo: entro 12 mesi dalla randomizzazione
entro 12 mesi dalla randomizzazione
Incidenza cumulativa di mortalità non da recidiva entro i primi 12 mesi dopo la randomizzazione.
Lasso di tempo: 12 mesi dopo la randomizzazione
12 mesi dopo la randomizzazione
Sopravvivenza libera da corticosteroidi, libera da malattia e globale entro i primi 12 mesi dopo la randomizzazione.
Lasso di tempo: 12 mesi dopo la randomizzazione
12 mesi dopo la randomizzazione
Recupero immunitario e microbiota: numero di pazienti con recupero immunitario completo (linfociti e cellule dendritiche) e correzione della disbiosi del microbiota entro i primi 12 mesi
Lasso di tempo: 12 mesi dopo la randomizzazione
12 mesi dopo la randomizzazione
Quality of Life (QoL)-1
Lasso di tempo: 12 Months

Evaluation by 1 questionnaire: EORTC QLQ-C30 (quality of life questionnaire) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30)
12 Months
Quality of Life (QoL)-2
Lasso di tempo: 12 Months

Evaluation by 1 questionnaire: FACT-BMT (Functional Assessment of Cancer Therapy - Bone Marrow Transplant)
12 Months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigatori

  • Investigatore principale: Mohamad Mohty, PU-PH, Assistance Publique - Hôpitaux de Paris

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 agosto 2018

Completamento primario (Effettivo)

24 gennaio 2025

Completamento dello studio (Effettivo)

24 gennaio 2025

Date di iscrizione allo studio

Primo inviato

31 luglio 2017

Primo inviato che soddisfa i criteri di controllo qualità

12 dicembre 2017

Primo Inserito (Effettivo)

13 dicembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PHRC-K 16-150
  • 2017 (Sovvenzione/contratto NIH degli Stati Uniti)
  • 2017-002691-98 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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