Porównanie skuteczności dodania metotreksatu (MTX) do obecnego standardowego leczenia pierwszego rzutu ostrej choroby przeszczep przeciw gospodarzowi (GVHD) za pomocą kortykosteroidów (MTX-aGVHD)
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
Status
Warunki
Warunki
Interwencja / Leczenie
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
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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-
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Paris, Francja, 75012
- Saint Antoine Hospital - Hematology Department
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
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
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: Methotrexate
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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. |
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Komparator placebo: Placebo
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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
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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
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
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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.
|
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Odsetek zaostrzeń GVHD w ciągu pierwszych 12 miesięcy po randomizacji.
Ramy czasowe: 12 miesięcy po randomizacji
|
12 miesięcy po randomizacji
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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
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w ciągu pierwszych 12 miesięcy po randomizacji
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Częstość występowania zakażenia ogólnoustrojowego i reaktywacji wirusa cytomegalii w ciągu 3 miesięcy od randomizacji
Ramy czasowe: w ciągu 3 miesięcy po randomizacji
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w ciągu 3 miesięcy po randomizacji
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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
|
|
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Skumulowana częstość zgonów bez nawrotu choroby w ciągu pierwszych 12 miesięcy po randomizacji.
Ramy czasowe: 12 miesięcy po randomizacji
|
12 miesięcy po randomizacji
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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
|
|
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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
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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
|
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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
Sponsor
Sponsor
Śledczy
Śledczy
- Główny śledczy: Mohamad Mohty, PU-PH, Assistance Publique - Hôpitaux de Paris
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
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)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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