A Phase II Trial to Evaluate the Safety and Activity of Single-agent Lenalidomide Given as Maintenance Therapy After Response to Second-line Therapy in Patients With Relapsed DLBCL, Not Eligible for High-dose Chemotherapy and ASCT (Autologous Stem-Cell Transplantation)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 1-year Progression-free Survival
研究概览
简要总结
This phase II multi-institutional trial will explore the safety and efficacy of lenalidomide monotherapy given as maintenance therapy following salvage chemo-immunotherapy in patients with relapsed or refractory chemosensitive diffuse large B-cell lymphoma
详细描述
Patients older than 65 years or younger but not eligible to high-dose chemotherapy and autologous stem cell transplantation with biopsy-proven diffuse large B-cell lymphoma relapsed to previous combination chemotherapy regimen ± rituximab, who achieved at least a partial response to second-line chemotherapy (ICE or DHAP/DHAOx ((D)examethasone (H)igh-dose (A)ra-C - cytarabine (P)latinol (cisplatin)) or MINE (Mesna Ifosfamide Mitoxantrone Etoposide) regimen) + rituximab will receive single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment until progression of disease. Dose reductions of study drug will be made in case of adverse events when reported as correlated and when clinically appropriate.
One-year progression free survival (PFS) will be the primary endpoint and overall survival, response rate and toxicity will be the secondary endpoints. With the null hypothesis (P0) of 1-year PFS of 30%, this study will consider a satisfactory efficacy of lenalidomide worth of further investigation a P1 corresponding to a 1-yr PFS of 50% (that is an absolute increase of 20% in terms of 1-yr progression-free survival). Considering a standard type I error (α) of 0,05 and a power of 80% (Type 2 error of 20%) 47 patients will be necessary for the trial.
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
- •Age > 65 years
- •Age < 65 but not eligible to high-dose chemotherapy and autologous stem cell transplantation
- •Biopsy-proven DLBCL relapsed to previous combination chemotherapy regimen ± rituximab
- •PR (Partial Response) or CR (Complete Response) to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab
- •ECOG (Eastern Cooperative Oncology Group) performance status score < 4
- •Female of childbearing potential (FCBP) must demonstrate to practice a proper contraception to avoid any pregnancy risk during the study and at least 28 days after the discontinuation of the study
- •Male subjects must agree to practice a proper contraception during any sexual contact with females childbearing potential
排除标准
- •CNS (Central Nervous System) involvement
- •Prior ASCT
- •TTP (Time To Progression) <6 months after first-line therapy
- •Use of experimental drugs during second-line salvage chemotherapy
- •Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus )
- •Active infectious disease
- •HIV, HBV (Hepatitis B Virus) or HCV (Hepatitis C Virus) - positivity
- •Impaired liver function (Bilirubin >2 x upper normal limit; ALT (alanine aminotransferase) /AST (aspartate aminotransferase) /GGT (γ-glutamyltransferase) > 3 x upper normal limit) at one month from salvage chemotherapy conclusion
- •Impaired renal function (creatinine clearance <50 ml/min) at one month from salvage chemotherapy conclusion
- •Absolute neutrophil count (ANC) <1000/microL
- •Platelet count <75.000 /mm3
- •Hemoglobin <9 g/dL
- •Non-co-operative behaviour or non-compliance
- •Psychiatric diseases or conditions that might impair the ability to give informed consent
- •Pregnant or lactating females
研究组 & 干预措施
Lenalidomide
single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
1-year Progression-free Survival
时间窗: 1-year
It is defined as the number of participants alive after 1 year from enrolment to progression or relapse of lymphoma (if post-induction disease status was PR (Partial Response) or CR (Complete Response), respectively). Patients alive at last follow-up will be censored.
次要结局
- Overall Survival(5 years)
- Progression Free Survival(5 years)
- Duration of Response(5 years)
- Progression(5 years)
研究者
Andrés José Maria Ferreri
Unit Head
IRCCS San Raffaele