Phase II Single Agent Lenalidomide (Revlimid) in Relapsed / Refratory Mantle Cell Lymphoma. - Lenalidomide Study

Plymouth Hospitals NHS Trust0 个研究点目标入组 26 人开始时间: 2008年9月2日最近更新: 2020年10月13日

适应症

试验速览

暂无简介。

•Male and female patients 18 years and older
•A confirmed mantle cell lymphoma which is refractory to, or relapsed following the completion of 2 or more anti-neoplastic therapies - All chemotherapy regimens are permissible
•Measrable disease
•Karnofsky Performance Status >/= 50% (ECOG 0-2)
•Absolute neutrophil count of >/= 1000 cells/uL, not related to lymphoma
•Platelets >/= 30,000 cells/uL
•Aspartate transaminase Toxic effects of previous therapy or surgery resolved to grade 2 or better
•Female patients who are either post-menopausal, sugically sterilised or willing to use 2 acceptable methods of birth control
•Male patients who agree to use an acceptable method of birth control for the duration of the study
•Patients who have given written informed consent, prior to any study related proceedures
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients known to be serologically positive for HBV, HCV or HIV
•Previous treatment with lenalidomide
•Any anti-neoplastic therapy within 3 weeks prior to Day 1 of Cycle 1
•Any nitrosoureas within 6 weeks prior to Day 1 of Cycle 1
•Treatment with Rituximab, Alemtuzumab or other unconjugated therapeutic antibody within 4 weeks prior to Day 1 of Cycle 1
•Radiation therapy within 3 weeks before Day 1 of Cycle 1
•Major surgery within 2 weeks prior to Day 1 of Cycle 1
•Active systemic infection requiring treatment
•Any concurrent active malignancy
•female patients who may be pregnant or breast-feeding
•Serious medical or psychiatric illness likely to interfere with participation in this study
•Concurrent treatment with another investigational agent

发起方