Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)
12 de setembro de 2014 atualizado por: Swedish Orphan Biovitrum
A Randomized, Blinded, Active-control Trial of Palifermin (rHuKGF) to Evaluate Oral Mucositis in Subjects With Hematologic Malignancies Undergoing Fractionated Total Body Irradiation (fTBI) and High Dose Chemotherapy With Autologous Peripheral Blood Progenitor Cell (PBPC) Transplantation
To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization [WHO] grade 3 and 4).
Visão geral do estudo
Status
Concluído
Tipo de estudo
Intervencional
Inscrição (Real)
47
Estágio
- Fase 3
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Written informed consent
- Subjects with: non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma
- Minimum of 1.5 x 10^6 CD34+ cells/kg cryopreserved and to be transplanted.
Exclusion Criteria:
- Cancer other than those specified in inclusion criteria above (except: adequately treated basal cell carcinoma of the skin)
- Prior bone marrow or peripheral blood stem cell transplantation - Negatively selected (purged) stem cell product - Current active infection or oral mucositis
- Congestive heart failure as defined by New York Heart Association class III or IV.
- History of or current diagnosis of pancreatitis
- Inadequate renal function (serum creatinine greater than 1.5x the upper limit of normal per the institutional guidelines)
- Inadequate liver function (direct bilirubin greater than 1.5x the upper limit of normal, aspartate aminotransferase (AST) greater than 3x upper limit of normal and/or alanine aminotransferase (ALT) greater than 3x upper limit of normal per the institutional guidelines)
- Inadequate pulmonary function as measured by a corrected diffusion capacity of carbon monoxide (DLCO) less than 50% of predicted.
- Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Palifermin 60 µg/kg for 3 days
Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
|
Administered as one daily intravenous bolus.
Outros nomes:
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
Outros nomes:
Administered as one daily intravenous bolus.
|
|
Experimental: Palifermin 180 μg/kg on Day -1
Palifermin 180 μg/kg on Day -1 and matched placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
|
Administered as one daily intravenous bolus.
Outros nomes:
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
Outros nomes:
Administered as one daily intravenous bolus.
|
|
Experimental: Palifermin 180 μg/kg on Day -2
Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
|
Administered as one daily intravenous bolus.
Outros nomes:
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
Outros nomes:
Administered as one daily intravenous bolus.
|
|
Experimental: Palifermin 180 μg/kg on Day -3
Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
|
Administered as one daily intravenous bolus.
Outros nomes:
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
Outros nomes:
Administered as one daily intravenous bolus.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4)
Prazo: Up to Day 28
|
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until severe OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
|
Up to Day 28
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Duration of Severe Oral Mucositis (WHO Grade 3 and 4)
Prazo: Up to Day 28
|
The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4).
Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.
|
Up to Day 28
|
|
Area Under the Curve (AUC) of Mouth and Throat Soreness Score
Prazo: From the first day of study drug administration through Day 28
|
The Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS.
The OMDQ was completed once daily beginning with the first day of study drug administration through Day 28.
The area under the curve of mouth and throat soreness score was assessed from the question "How much mouth and throat soreness did you experience in the past 24 hours?"
Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness).
A higher value in MTS AUC indicates worse self-assessed MTS.
|
From the first day of study drug administration through Day 28
|
|
Number of Participants With Parenteral or Transdermal Opioid Analgesic Use
Prazo: Up to Day 28
|
Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.
|
Up to Day 28
|
|
Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis
Prazo: Up to Day 28
|
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
|
Up to Day 28
|
|
Duration of WHO Grade 2, 3 or 4 Oral Mucositis
Prazo: Up to Day 28
|
The duration of grade 2, 3 or 4 oral mucositis (OM) was calculated as the number of days from the onset of grade 2, 3 or 4 OM (first time a WHO grade 2, 3 or 4 was observed) to the day when WHO grade 2 - 4 OM was resolved (first time WHO grade less than 2 was observed after last WHO grade 2, 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 2, 3 or 4 during the study. OM was evaluated using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible. |
Up to Day 28
|
|
Number of Participants With WHO Grade 4 Oral Mucositis
Prazo: Up to Day 28
|
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
|
Up to Day 28
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2005
Conclusão Primária (Real)
1 de fevereiro de 2006
Conclusão do estudo (Real)
1 de dezembro de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
22 de abril de 2005
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de abril de 2005
Primeira postagem (Estimativa)
25 de abril de 2005
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
15 de setembro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de setembro de 2014
Última verificação
1 de setembro de 2014
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Gastroenterite
- Doenças estomatognáticas
- Doenças bucais
- Mucosite
- Estomatite
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antirreumáticos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Agentes Antineoplásicos Alquilantes
- Agentes Alquilantes
- Agonistas Mieloablativos
- Agentes Antineoplásicos Fitogênicos
- Inibidores da Topoisomerase II
- Inibidores da Topoisomerase
- Ciclofosfamida
- Etoposídeo
Outros números de identificação do estudo
- 20040212
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