Comparar a eficácia da adição de metotrexato (MTX) ao tratamento de primeira linha padrão da doença aguda do enxerto contra o hospedeiro (GVHD) com corticosteróides (MTX-aGVHD)
Um estudo randomizado multicêntrico em fase III duplo-cego comparando a terapia de tratamento padrão isolada versus corticosteróides e metotrexato de baixa dose (MTX) para o tratamento de primeira linha da doença aguda do enxerto contra o hospedeiro após transplante alogênico de células-tronco
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
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Tipo de estudo
Inscrição (Real)
Inscrição
Estágio
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Paris, França, 75012
- Saint Antoine Hospital - Hematology Department
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Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador de 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization.
Prazo: 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
|
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (1).
Prazo: 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.
|
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (2).
Prazo: Evaluation will be performed at Day 8
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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).
Prazo: Evaluation will be performed at Day 15
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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
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (4).
Prazo: Evaluation will be performed at Day 22
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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
|
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (5).
Prazo: Evaluation will be performed at Day 28
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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
|
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (6).
Prazo: Evaluation will be performed at Day 36
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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
|
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (7).
Prazo: 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
|
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (8).
Prazo: 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
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (9).
Prazo: 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
|
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (10)
Prazo: 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
|
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (11).
Prazo: Evaluation will be performed at Day 92
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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
|
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (12).
Prazo: Evaluation will be performed at Day 102
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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
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (13).
Prazo: Evaluation will be performed at 5 months after randomization.
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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.
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (14).
Prazo: Evaluation will be performed at 6 months after randomization.
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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.
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (17).
Prazo: Evaluation will be performed at 9 months after randomization .
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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 .
|
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Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (18).
Prazo: 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.
|
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Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (19).
Prazo: 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).
Prazo: 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).
Prazo: 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.
|
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Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (20).
Prazo: 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.
|
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Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (21).
Prazo: Evaluation will be performed at Day 22.
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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.
|
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Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (22).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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.
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
A incidência de eventos adversos graves nos primeiros 12 meses após a randomização
Prazo: 12 meses após a randomização
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12 meses após a randomização
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A proporção de remissão completa (CR), resposta parcial muito boa (VGPR), resposta parcial (PR), resposta mista (MR), sem resposta (NR) e progressão no dia 28, dia 56 e melhor resposta nos primeiros 12 meses após a randomização.
Prazo: no dia 28, dia 56 e melhor resposta nos primeiros 12 meses após a randomização.
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no dia 28, dia 56 e melhor resposta nos primeiros 12 meses após a randomização.
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A proporção de exacerbação de GVHD nos primeiros 12 meses após a randomização.
Prazo: 12 meses após a randomização
|
12 meses após a randomização
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Incidência cumulativa de GVHD crônica geral e grave conforme avaliada pelos Critérios de Consenso do NIH nos primeiros 12 meses após a randomização (Jagasia, Greinix et al. 2015, Lee, Wolff et al. 2015).
Prazo: nos primeiros 12 meses após a randomização
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nos primeiros 12 meses após a randomização
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Incidência de infecção sistêmica e reativação do CMV (citomegalovírus) dentro de 3 meses após a randomização
Prazo: dentro de 3 meses após a randomização
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dentro de 3 meses após a randomização
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Incidência de reativação de EBV (vírus Epstein-Barr) e doença linfoproliferativa pós-transplante em 12 meses após a randomização
Prazo: dentro de 12 meses após a randomização
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dentro de 12 meses após a randomização
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Incidência cumulativa de mortalidade sem recaída nos primeiros 12 meses após a randomização.
Prazo: 12 meses após a randomização
|
12 meses após a randomização
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Sobrevida livre de corticosteróides, livre de doença e global nos primeiros 12 meses após a randomização.
Prazo: 12 meses após a randomização
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12 meses após a randomização
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Recuperação imunológica e microbiota: número de pacientes com recuperação imunológica completa (linfócitos e células dendríticas) e correção da disbiose da microbiota nos primeiros 12 meses
Prazo: 12 meses após a randomização
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12 meses após a randomização
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Quality of Life (QoL)-1
Prazo: 12 Months
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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
Prazo: 12 Months
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Evaluation by 1 questionnaire: FACT-BMT (Functional Assessment of Cancer Therapy - Bone Marrow Transplant) |
12 Months
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Mohamad Mohty, PU-PH, Assistance Publique - Hôpitaux de Paris
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Real)
Conclusão Primária
Conclusão do estudo (Real)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- PHRC-K 16-150
- 2017 (Concessão/Contrato do NIH dos EUA)
- 2017-002691-98 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
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