A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®) in Subjects With Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 54
- 试验地点
- 45
- 主要终点
- Participants Categorized by Best Response as Determined by Investigator
研究概览
简要总结
This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase.
Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles). Subjects may continue participation in the Treatment Phase of the study for a maximum duration of 24 months, or until disease progression or unacceptable adverse events develop.
All subjects who discontinue the Treatment Phase for any reason will continue to be followed until progression of disease or until next lymphoma treatment is given, whichever comes first, during the Follow-up Phase.
Objectives:
Primary:
• To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival.
Secondary:
• To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory T-cell NHL.
详细描述
Study was terminated. Study data assessment revealed that study drug is active, but is not likely to be sufficiently active as a single agent in this population for registration purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must understand and voluntarily sign an informed consent form.
- •Must be ≥ 18 years of age at the time of signing the informed consent form.
- •Must be able to adhere to the study visit schedule and other protocol requirements.
- •Biopsy-proven T-cell Non-Hodgkin's Lymphoma, either:
- •Peripheral T-cell Lymphoma (PTCL) whatever the subtype, or
- •Cutaneous T-cell Lymphoma (CTCL), but only the subtype mycosis fungoides.
- •Relapsed or refractory to previous therapy for T-cell Non-Hodgkin's Lymphoma.
- •Must have received at least one prior combination chemotherapy regimen. There is no limit on the number of prior therapies.
排除标准
- •Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.
研究组 & 干预措施
Lenalidomide
Open-label, oral lenalidomide monotherapy
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Participants Categorized by Best Response as Determined by Investigator
时间窗: Up to 24 months
Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail): * Complete Response(CR): Complete disappearance of all detectable disease * Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow * Partial Response(PR): \>50% decrease in six largest nodes/nodal masses * Stable Disease(SD): Less than PR, but not progressive disease * Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by \>=50% in previous sites * Progressive Disease(PD): \>=50% increase from low in PR/Non-Responders
次要结局
- Duration of Response(Up to 24 months)
- Time-to-Progression(Up to 24 months)
- Progression-Free Survival(Up to 24 months)
- Safety(Up to 24 months)