A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 43
- 试验地点
- 15
- 主要终点
- Percentage of Participants With Response
研究概览
简要总结
Subjects who qualify will receive lenalidomide daily on days 1-21 of every 28-day cycle. Treatment will continue for up to 52 weeks or until disease progression; subjects who achieve a Complete Response (CR) will receive an additional 2 cycles of treatment prior to discontinuation. Subjects will be followed for progression free survival following discontinuation from the treatment phase
详细描述
Participants who qualified for enrollment into the study entered the treatment phase and received single-agent lenalidomide 25 mg once daily on Days 1 to 21 of every 28-day cycle. The treatment phase began on Day 1 of Cycle 1. Study visits were scheduled to occur every 28 days to coincide with the beginning of a new cycle. The start date of a new cycle was delayed if adverse events (AEs) occurred, in which case the visit date for the start of the following cycle was scheduled 28 days after the actual start date of the delayed cycle. Efficacy and safety assessments, including complete blood counts (CBCs) were performed at least every 2 weeks during Cycles 1 to 4 of the treatment phase. Participants continued in the treatment phase of the study for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
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
- •Understand and voluntarily sign an informed consent form.
- •Age greater than or equal to 18 years at the time of signing the informed consent form
- •Able to adhere to the study visit schedule and other protocol requirements
- •Biopsy-proven non-Hodgkin's lymphoma
- •Indolent lymphoma the following histologies are acceptable: a. Follicular center lymphoma, grades 1, 2; b. Extranodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT) type, c. Nodal marginal zone B-cell lymphoma d. Splenic marginal zone B-cell lymphoma, e. Small lymphocytic lymphoma (SLL), f. Lymphoplasmacytoid lymphoma
- •Relapsed or refractory to previous therapy for lymphoma. Participants must have received at least one prior treatment regimen such as radiation, immunotherapy, chemotherapy, or radioimmunotherapy, and be ineligible or unwilling to undergo an autologous stem cell transplant. There is no limit on the number of prior therapies
- •Participants must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or
- •Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.
排除标准
- •Any of the following laboratory abnormalities
- •Absolute neutrophil count (ANC) <1,500 cells/mm^3 (1.5 x 10^9/L)
- •Platelet count <100,000/mm^3 (100 x 10^9/L)
- •Serum creatinine >2.5 mg/dL (221 mmol/L)
- •Serum Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic-pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) >5.0 x upper limit of normal (ULN)
- •Serum total bilirubin >2.0 mg/dL (34 mmol/L)
- •Any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •All participants with Central Nervous System (CNS) disease with the exception of those subjects whose CNS disease has been treated with chemotherapy, radiotherapy or surgery and remains asymptomatic, with no active CNS disease, as shown by lumbar puncture, computerized tomography (CT) scan or Magnetic resonance imaging (MRI), for at least 6 months.
- •Prior history of malignancies other than non-Hodgkin's lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the participant has been free of the disease for > or equal to 1 year.
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from signing the informed consent form.
- •Known positive for human immunodeficiency virus (HIV).
- •Pregnant or lactating females.
- •Prior > or equal to grade 3 allergic reaction/hypersensitivity to thalidomide.
- •Prior > or equal to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
- •Prior use of lenalidomide.
- •Use of any standard or experimental anti-cancer drug therapy within 28 days of day 1 of study drug therapy.
- •Known active Hepatitis C.
研究组 & 干预措施
Lenalidomide
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Percentage of Participants With Response
时间窗: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months
Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities. Cru: Criteria for CR above but with 1 or more of the following: • A residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD) • Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). PR: ≥ 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD.
次要结局
- Percentage of Participants With Tumor Control(From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months)
- The Duration of Response(From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months)
- Progression Free Survival (PFS)(From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months)
- Number of Participants With Adverse Events (AEs)(From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months.)