Allogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for High-risk Relapsed or Refractory CLL - HOVON 88 C

HOVON Foundation0 个研究点目标入组 50 人开始时间: 2008年8月13日最近更新: 2018年8月20日

适应症

试验速览

暂无简介。

•- B-CLL confirmed according to WHO Classification;
•- Fludarabine refractory, defined as
•no response or relapse within 12 months after the last administration of fludarabine monotherapy or fludarabine containing regimen, and needing treatment, or
•Refractory or relapsed and needing treatment and having deletion of 17p13, or
•Refractory or relapsed within 24 months after the last administration of fludarabine combined with a monoclonal antibody and needing treatment;
•- Age 18-70 years inclusive;
•- WHO performance status = 2 (see appendix E);
•- HCT-CI = 2 (see appendix F);
•- Written informed consent.
•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 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•- Intolerance to exogenous protein administration
•- Previously treated with DHAP
•- Richter’s transformation;
•- Suspected or documented CNS involvement by CLL;
•- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
•- Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
•- Severe neurological or psychiatric disease;
•- Significant hepatic dysfunction (serum bilirubin or transaminases = 3 times upper limit of normal) except when caused by leukemic infiltration;
•- Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
•- History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
•- Active, uncontrolled infections;
•- Patient known to be HIV-positive;
•- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;

发起方

HOVON Foundation