CLARET: CLL Levels following Alemtuzumab in Responders to Early Therapy: A randomised, phase III trial to assess alemtuzumab consolidation therapy in patients with chronic lymphocytic leukaemia (CLL) who have responded to previous therapy. - CLARET Version 3.0

eeds Teaching Hospitals NHS Trust0 个研究点目标入组 116 人开始时间: 2012年5月2日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•At least 18 years old
•Previous confirmation of B-CLL with a characteristic immunophenotype (for example, CD5+, CD19+, CD23+ lymphoproliferative disorder) on peripheral blood flow cytometry
•Peripheral B-Cell count <5x109l
•Maximum of three prior therapies received for CLL treatment
•First MRD positive peripheral blood sample between 6 and 12 months since completing most recent therapy for CLL
•Response to most recent chemotherapy treatment for CLL with PR, CRi or CR
•Absence of clinically or radiologically evident lymphadenopathy (largest lymph node <2cm in minimum diameter)
•Creatinine and bilirubin <2 times upper limit of normal unless secondary to direct infiltration of the liver by CLL or haemolysis
•World Health Organisation (WHO) performance status (PS) of 0 or 1
•Able to provide written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 0

•Patients with the following characteristics are ineligible for this trial:
•Disease progression after response to latest therapy
•Active infection
•Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanised monoclonal antibodies
•Previous treatment with alemtuzumab
•Pregnancy, lactation or women of child-bearing potential unwilling to use medically approved contraception whilst receiving treatment and for 6 months after treatment has finished
•Men whose partners are capable of having children but who are not willing to use appropriate medically approved contraception whilst receiving treatment and for 6 months after treatment has finished, unless they are surgically sterile
•CNS involvement with CLL
•Mantle cell lymphoma
•Other severe, concurrent diseases or mental disorders
•HIV positive
•Patient has active or prior Hepatitis B or C
•Active secondary malignancy excluding basal cell carcinoma
•Persisting severe pancytopenia (neutrophils <0.5 x 109/l or platelets <50 x 109/l) or transfusion dependent anaemia
•Active haemolysis
•Patients previously treated with allogeneic SCT

发起方

eeds Teaching Hospitals NHS Trust