- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00720603
This is a Multi-center, Single Arm, Open Label Study Intended to Provide Expanded Access to Plerixafor for Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) Who Are to Receive Treatment With an Autologous Peripheral Stem Cell Transplant. (EAP)
19 de março de 2015 atualizado por: Genzyme, a Sanofi Company
Expanded Acess Study of Plerixafor and G-CSF for the Mobilization and Collection of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease or Multiple Myeloma
The purpose of this program is to provide expanded access to plerixafor for patients with NHL, HD, or MM who are to receive treatment with an autologous peripheral stem cell transplant.
Visão geral do estudo
Status
Não está mais disponível
Intervenção / Tratamento
Descrição detalhada
The Expanded Access Program (EAP)(protocol number MOZ00607) is an open label study intended to provide access to plerixafor for patients with non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma who are to receive treatment with an autologous hematopoietic stem cell transplant.
Patients who have previously failed stem cell mobilization attempts or who have previously received an autologous or allogeneic stem cell transplant are not eligible to enroll in this program.
The standard of care regimen for stem cell mobilization includes a growth factor, G-CSF, to increase peripheral blood stem cells.
Plerixafor is given on the evening prior to doses of standard treatment with G-CSF.
The combination of G-CSF and plerixafor has the potential to increase the number of circulating stem cells.
The stem cells develop into specialized white blood cells and platelets that are necessary for immune system function and normal blood clotting.
The stem cells are removed by a process called apheresis, in which blood is drawn from the patient, the stem cells are separated from the plasma, and the plasma is returned to the patient.
The separated stem cells are frozen, similar to the blood banking process.
The patient then receives chemotherapy according to the institutional standard.
After chemotherapy, stem cell transplant is intended to replenish cells in the bone marrow that may be destroyed by chemotherapy.
Tipo de estudo
Acesso expandido
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
N/D
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Diagnosis of MM, NHL, or HD.
- Eligible for a planned autologous peripheral stem cell transplantation.
- Written informed consent.
- At least 18 years of age (inclusive).
- Easter Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, I.e., eligible by institutional standards for autologous stem cell transplant.
- Male and female patients of childbearing potential agree to use appropriate form of contraception (i.e., condom, diaphragm cervical cap, etc.) while on study and for at least 3 months following the last treatment. Female patients of child-producing potential must have a negative serum pregnancy test confirmed within 7 days of beginning mobilization therapy.
- White blood cell (WBC) count greater than or equal to 2.5x10^9/L.
- Absolute neutrophil count (ANC) greater than or equal to 1.5x10^9/L.
- Platelet count greater than or equal to 100x10^9/L.
- Serum creatinine less than or equal to 2.2 mg/ dL.
- AST/SGOT, ALT/SGPT, and total bilirubin less than 2.5 x upper limit of normal (ULN).
Exclusion Criteria:
- History of acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), acute myelocytic leukemia (AML), chronic myelocytic leukemia (CML), myelodysplastic syndrome (MDS), plasma cell leukemia or other leukemia.
- Failed previous CD34+ cell collection attempts.
- Prior autologous or allogenic transplantation.
- less than 4 weeks since last anti-cancer therapy (including chemotherapy, biologic/immunologic, radiation) or less than 6 weeks if prior therapy was with nitrosourea or mitomycin (for therapies with prolonged effects, a treatment-free interval of at least 2 half-lives should be considered) with the exception of the following: Treatment with thalidomide, dexamethasone, lenalidomide (Revlimid®), and/or bortezomib (Velcade®) is allowed up to 7 days prior to the first dose of G-CF.
- Bone marrow involvement greater than 20% assessed based on the most recent bone marrow aspirate or biopsy.
- Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization.
- HIV positive.
- Active hepatitis B (positive HBsAg) or hepatitis C.
- Acute infection (febrile, i.e., temperature greater than 38 degrees Celsius/100.4 degrees Fahrenheit) within 24 hours prior to dosing or antibiotic therapy within 1 week of enrollment.
- Hypercalcemia as evidenced by greater than 1 mg/dL above ULN.
- Previously received investigational therapy with 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilization phase.
- Central nervous system involvement including brain metastases of leptomeningeal disease.
- Pregnant or nursing women.
- ECG or study result (exercize study, scan) indicative of previously undiagnosed cardiac ischemia or a history of clinically significant rhythm disturbance (arrhythmias), or other conduction abnormality in the last year that in the opinion of the Investigator warrants exclusion of the subject from the trial.
- Co-morbid conditions(s), which in the opinion of the Investigator, renders the patient at high risk from treatment complications or impairs their ability to comply with the study treatment and protocol.
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?
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 de inscrição no estudo
Enviado pela primeira vez
21 de julho de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de julho de 2008
Primeira postagem (Estimativa)
23 de julho de 2008
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
24 de março de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de março de 2015
Última verificação
1 de março de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças cardiovasculares
- Doenças Vasculares
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Neoplasias
- Distúrbios Linfoproliferativos
- Doenças Linfáticas
- Distúrbios imunoproliferativos
- Doenças Hematológicas
- Distúrbios hemorrágicos
- Distúrbios hemostáticos
- Paraproteinemias
- Distúrbios das Proteínas Sanguíneas
- Linfoma
- Mieloma múltiplo
- Neoplasias de Células Plasmáticas
- Doença de Hodgkin
- Linfoma Não-Hodgkin
- Agentes Anti-Infecciosos
- Antivirais
- Agentes anti-HIV
- Antirretrovirais
- Plerixafor
Outros números de identificação do estudo
- MOZ00607
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