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

HOVO0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年6月18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.

•- 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

HOVO