A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 9
- 试验地点
- 91
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR).
This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically-proven mantle cell non-Hodgkin's lymphoma,
- •One of the following first-line induction chemotherapy regimens with rituximab: (1) combination regimen containing all of the following components: cyclophosphamide, vincristine, adriamycin and a glucocorticoid; (2) Fludarabine containing regimen such as FC (fludarabine, cyclophosphamide)
- •Achieved a PR or better response after the first-line induction chemotherapy regimen (assessed by 2007 Revised Response Criteria for Malignant Lymphoma)
- •ECOG performance status score of ≤ 2
- •Willing to follow pregnancy precaution
排除标准
- •Patients who have received more than 1 line of induction chemotherapy;
- •Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are ineligible;
- •Patients who achieved stable disease or progressive disease as best response with first line-induction chemotherapy;
- •Any of the following laboratory abnormalities:
- •Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5*10^9/L)
- •Platelet count < 60,000/mm^3 (60*10^9/L)
- •Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) > 3.0 times upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
- •Serum bilirubin > 1.5 times ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma
- •Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of < 30 mL /min
- •Active or any history of central nervous system (CNS) lymphoma or leptomeningeal involvement by lymphoma
- •Subjects at high risk for deep vein thrombosis (DVT) not willing to take DVT prophylaxis
- •Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
研究组 & 干预措施
Lenalidomide
Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
干预措施: Lenalidomide (Drug)
Placebo
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
干预措施: Placebo (Other)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: up to 7 years
PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir. Study terminated prematurely. Analysis not conducted.
次要结局
- Overall Survival(up to 7 years)
- Participants With Treatment Emergent Adverse Events (TEAEs)(up to 9 months)
- Time to Progression(up to 7 years)
- Time to Treatment Failure(up to 2 years)
- Participants With a Tumor Response(up to 7 years)