Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Porównanie skuteczności dodania metotreksatu (MTX) do obecnego standardowego leczenia pierwszego rzutu ostrej choroby przeszczep przeciw gospodarzowi (GVHD) za pomocą kortykosteroidów (MTX-aGVHD)

15 września 2026 zaktualizowane przez: Assistance Publique - Hôpitaux de Paris

Wieloośrodkowe randomizowane badanie fazy III z podwójnie ślepą próbą, porównujące standardową terapię samodzielną z kortykosteroidami i metotreksatem w małej dawce (MTX) w leczeniu pierwszego rzutu ostrej choroby przeszczep przeciw gospodarzowi po allogenicznym przeszczepieniu komórek macierzystych

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

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

104

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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
Lek: 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.
Komparator 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
Lek: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization.
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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)
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Częstość występowania ciężkich zdarzeń niepożądanych w ciągu pierwszych 12 miesięcy po randomizacji
Ramy czasowe: 12 miesięcy po randomizacji
12 miesięcy po randomizacji
Odsetek całkowitej remisji (CR), bardzo dobrej częściowej odpowiedzi (VGPR), częściowej odpowiedzi (PR), mieszanej odpowiedzi (MR), braku odpowiedzi (NR) oraz progresji w 28., 56. dniu i najlepszej odpowiedzi w ciągu pierwszych 12 miesięcy po randomizacji.
Ramy czasowe: w dniu 28, dniu 56 i najlepsza odpowiedź w ciągu pierwszych 12 miesięcy po randomizacji.
w dniu 28, dniu 56 i najlepsza odpowiedź w ciągu pierwszych 12 miesięcy po randomizacji.
Odsetek zaostrzeń GVHD w ciągu pierwszych 12 miesięcy po randomizacji.
Ramy czasowe: 12 miesięcy po randomizacji
12 miesięcy po randomizacji
Skumulowana częstość występowania ogólnej i ciężkiej przewlekłej GVHD, jak oceniono za pomocą kryteriów NIH Consensus Criteria w ciągu pierwszych 12 miesięcy po randomizacji (Jagasia, Greinix i in. 2015, Lee, Wolff i in. 2015).
Ramy czasowe: w ciągu pierwszych 12 miesięcy po randomizacji
w ciągu pierwszych 12 miesięcy po randomizacji
Częstość występowania zakażenia ogólnoustrojowego i reaktywacji wirusa cytomegalii w ciągu 3 miesięcy od randomizacji
Ramy czasowe: w ciągu 3 miesięcy po randomizacji
w ciągu 3 miesięcy po randomizacji
Częstość występowania reaktywacji EBV (wirusa Epsteina-Barr) i choroby limfoproliferacyjnej po przeszczepie w ciągu 12 miesięcy po randomizacji
Ramy czasowe: w ciągu 12 miesięcy po randomizacji
w ciągu 12 miesięcy po randomizacji
Skumulowana częstość zgonów bez nawrotu choroby w ciągu pierwszych 12 miesięcy po randomizacji.
Ramy czasowe: 12 miesięcy po randomizacji
12 miesięcy po randomizacji
Wolne od kortykosteroidów, wolne od choroby i całkowite przeżycie w ciągu pierwszych 12 miesięcy po randomizacji.
Ramy czasowe: 12 miesięcy po randomizacji
12 miesięcy po randomizacji
Odnowa odporności i mikrobiota: liczba pacjentów z całkowitą regeneracją odporności (limfocyty i komórki dendrytyczne) oraz korekta dysbiozy mikroflory w ciągu pierwszych 12 miesięcy
Ramy czasowe: 12 miesięcy po randomizacji
12 miesięcy po randomizacji
Quality of Life (QoL)-1
Ramy czasowe: 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
Ramy czasowe: 12 Months

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Assistance Publique - Hôpitaux de Paris

Śledczy

  • Główny śledczy: Mohamad Mohty, PU-PH, Assistance Publique - Hôpitaux de Paris

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

16 sierpnia 2018

Zakończenie podstawowe (Rzeczywisty)

24 stycznia 2025

Ukończenie studiów (Rzeczywisty)

24 stycznia 2025

Daty rejestracji na studia

Pierwszy przesłany

31 lipca 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 grudnia 2017

Pierwszy wysłany (Rzeczywisty)

13 grudnia 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • PHRC-K 16-150
  • 2017 (Grant/umowa NIH USA)
  • 2017-002691-98 (Numer EudraCT)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj