NCT01060904已完成1 期
A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Incidence of adverse events and laboratory abnormalities
研究概览
简要总结
The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
- •Measurable disease of at least 1.5 cm
- •Eastern Cooperative Oncology Group performance status <3
排除标准
- •History of another primary malignancy that has not been in remission for at least 3 years
- •Known cerebral/meningeal disease
研究组 & 干预措施
1
Experimental
brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
干预措施: bleomycin (Drug)
1
Experimental
brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
干预措施: brentuximab vedotin (Drug)
1
Experimental
brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
干预措施: doxorubicin (Drug)
1
Experimental
brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
干预措施: vinblastine (Drug)
1
Experimental
brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
干预措施: dacarbazine (Drug)
2
Experimental
brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)
干预措施: doxorubicin (Drug)
2
Experimental
brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)
干预措施: vinblastine (Drug)
2
Experimental
brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)
干预措施: dacarbazine (Drug)
2
Experimental
brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)
干预措施: brentuximab vedotin (Drug)
结局指标
主要结局
Incidence of adverse events and laboratory abnormalities
时间窗: Through 1 month after last dose
次要结局
- Brentuximab vedotin concentration in blood(Through 1 month after last dose)
- Antitherapeutic antibodies in blood(Through 1 month after last dose)
- Best clinical response(Through 1 month after last dose)
研究者
研究点 (4)
Loading locations...
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终止
1 期
Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ LymphomasAdult Grade III Lymphomatoid GranulomatosisAdult Nasal Type Extranodal NK/T-cell LymphomaAngioimmunoblastic T-cell LymphomaContiguous Stage II Adult Burkitt LymphomaContiguous Stage II Adult Diffuse Large Cell LymphomaContiguous Stage II Adult Diffuse Mixed Cell LymphomaContiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaContiguous Stage II Adult Immunoblastic Large Cell LymphomaContiguous Stage II Adult Lymphoblastic LymphomaContiguous Stage II Grade 1 Follicular LymphomaContiguous Stage II Grade 2 Follicular LymphomaContiguous Stage II Grade 3 Follicular LymphomaContiguous Stage II Mantle Cell LymphomaContiguous Stage II Marginal Zone LymphomaContiguous Stage II Small Lymphocytic LymphomaCutaneous B-cell Non-Hodgkin LymphomaEpstein-Barr Virus InfectionExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaIntraocular LymphomaNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Adult Burkitt LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Mixed Cell LymphomaNoncontiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaNoncontiguous Stage II Adult Immunoblastic Large Cell LymphomaNoncontiguous Stage II Adult Lymphoblastic LymphomaNoncontiguous Stage II Grade 1 Follicular LymphomaNoncontiguous Stage II Grade 2 Follicular LymphomaNoncontiguous Stage II Grade 3 Follicular LymphomaNoncontiguous Stage II Mantle Cell LymphomaNoncontiguous Stage II Marginal Zone LymphomaNoncontiguous Stage II Small Lymphocytic LymphomaNoncutaneous Extranodal LymphomaPeripheral T-cell LymphomaProgressive Hairy Cell Leukemia, Initial TreatmentRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaRefractory Hairy Cell LeukemiaSmall Intestine LymphomaSplenic Marginal Zone LymphomaStage I Adult Burkitt LymphomaStage I Adult Diffuse Large Cell LymphomaStage I Adult Diffuse Mixed Cell LymphomaStage I Adult Diffuse Small Cleaved Cell LymphomaStage I Adult Hodgkin LymphomaStage I Adult Immunoblastic Large Cell LymphomaStage I Adult Lymphoblastic LymphomaStage I Adult T-cell Leukemia/LymphomaStage I Cutaneous T-cell Non-Hodgkin LymphomaStage I Grade 1 Follicular LymphomaStage I Grade 2 Follicular LymphomaStage I Grade 3 Follicular LymphomaStage I Mantle Cell LymphomaStage I Marginal Zone LymphomaStage I Small Lymphocytic LymphomaStage IA Mycosis Fungoides/Sezary SyndromeStage IB Mycosis Fungoides/Sezary SyndromeStage II Adult Hodgkin LymphomaStage II Adult T-cell Leukemia/LymphomaStage II Cutaneous T-cell Non-Hodgkin LymphomaStage IIA Mycosis Fungoides/Sezary SyndromeStage IIB Mycosis Fungoides/Sezary SyndromeStage III Adult Burkitt LymphomaStage III Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Mixed Cell LymphomaStage III Adult Diffuse Small Cleaved Cell LymphomaStage III Adult Hodgkin LymphomaStage III Adult Immunoblastic Large Cell LymphomaStage III Adult Lymphoblastic LymphomaStage III Adult T-cell Leukemia/LymphomaStage III Cutaneous T-cell Non-Hodgkin LymphomaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Grade 3 Follicular LymphomaStage III Mantle Cell LymphomaStage III Marginal Zone LymphomaStage III Small Lymphocytic LymphomaStage IIIA Mycosis Fungoides/Sezary SyndromeStage IIIB Mycosis Fungoides/Sezary SyndromeStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Mixed Cell LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Adult Hodgkin LymphomaStage IV Adult Immunoblastic Large Cell LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Adult T-cell Leukemia/LymphomaStage IV Cutaneous T-cell Non-Hodgkin LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Small Lymphocytic LymphomaStage IVA Mycosis Fungoides/Sezary SyndromeStage IVB Mycosis Fungoides/Sezary SyndromeT-cell Large Granular Lymphocyte LeukemiaTesticular LymphomaUntreated Hairy Cell LeukemiaWaldenström MacroglobulinemiaAnaplastic Large Cell LymphomaPost-transplant Lymphoproliferative DisorderNCT01805037Northwestern University20