Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma
Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma
Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell.
The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you will receive in this research study are approved for use in people with Hodgkin Lymphoma. A drug called bleomycin is usually included with AVD, but since it appears to be a less effective drug with significant potential risks, it is being replaced in this study with the drug brentuximab.
In this research study, the investigators are looking to see whether brentuximab in combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Each treatment cycle is 28 days. You will receive brentuximab alone on Day 1 and 15 of the first cycle (lead-in cycle). After cycle 1, you will receive brentuximab combined with AVD on Day 1 and 15 for 4-6 cycles, depending on your response to therapy. Brentuximab and AVD will be given to you by intravenous infusion (IV).
The following test and procedures will be performed on Days 1 and 15 of each cycle:
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Physical exam and vital signs
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- Research blood sample to look at markers to see how your body is responding to study medication
- PET-CT scan prior to completing cycle 2 of combination brentuximab/AVD
After the final dose of the study drug: The following assessments will be performed within one month of your last dose of study medication:
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Physical exam and vital signs
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- Research blood sample to look at markers to see how your body is responding to study medication
- PET-CT scan Follow up will include the following
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Review and Physical exam
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- CT scans
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Florida
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Tampa, Florida, Estados Unidos, 33612
- Moffitt Cancer Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hosptial
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Previously untreated stage IA, IB, IIA or IIB classical Hodgkin Lymphoma
- Non-bulky disease defined as less than 10 cm in maximal diameter
- Measurable disease greater than or equal to 1.5 cm
- ECOG performance status of 0 or 2
- Willing to use 2 effective forms of birth control
Exclusion Criteria:
- No prior chemotherapy or radiotherapy for Hodgkin lymphoma
- Not receiving any other investigational agents
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Adriamycin, Vinblastine, Dacarbazine or brentuximab
- No pre-existing grade 3 or greater neuropathy
- No uncontrolled intercurrent illness
- Not pregnant or breastfeeding
- No history of a different malignancy unless disease free for at least one year
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Treatment Arm
Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
|
2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
Outros nomes:
Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Complete Response Rate
Prazo: End of Therapy (median duration of four months)
|
Complete response rate at the end of therapy as measured by Positron emission tomography-computed tomography (PET/CT).
Response is evaluated using Revised International Working Group Criteria.
Complete response is defined as disappearance of all evidence of disease.
|
End of Therapy (median duration of four months)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Response Rate After One Cycle of Brentuximab
Prazo: 28 days
|
The number of participants achieving a Partial Response (PR) or Complete Response (CR) after one cycle of Brentuximab monotherapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.
|
28 days
|
|
Overall Response Rate
Prazo: End of Therapy (median duration of four months)
|
The number of participants achieving a Partial Response (PR) or Complete Response (CR) at the end of therapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.
|
End of Therapy (median duration of four months)
|
|
Grade III or IV Adverse Events
Prazo: 2 years
|
A summary of the grade 3 or 4 adverse events experienced by participants as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
The data is shown as the number of participants that experienced at least one grade 3 or 4 adverse event for each of the specified toxicities.
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jeremy Abramson, M.D., Massachusetts General Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Neoplasias
- Distúrbios Linfoproliferativos
- Doenças Linfáticas
- Distúrbios imunoproliferativos
- Linfoma
- Doença de Hodgkin
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Agentes Antineoplásicos Alquilantes
- Agentes Alquilantes
- Agentes Antineoplásicos Fitogênicos
- Inibidores da Topoisomerase II
- Inibidores da Topoisomerase
- Agentes Antineoplásicos Imunológicos
- Antibióticos, Antineoplásicos
- Doxorrubicina
- Doxorrubicina lipossomal
- Dacarbazina
- Brentuximabe Vedotin
- Vinblastina
Outros números de identificação do estudo
- 11-462
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