Eradication of minimal residual disease (MRD) in chronic lymphocytic leukaemia (CLL) with alemtuzumab: a Phase II study

eeds Teaching Hospitals NHS Trust (UK)0 个研究点目标入组 47 人开始时间: 2006年1月20日最近更新: 2022年4月19日

适应症

试验速览

•1. At least 18 years old
•2. Written informed consent
•3. Previous confirmation of B-cell CLL with a characteristic immunophenotype on peripheral blood flow cytometry
•4. Creatinine and bilirubin <2 x upper limit of normal unless secondary to direct infiltration of the liver by CLL or haemolysis
•5. Must have achieved a complete remission or good partial remission after therapy for CLL
•6. At least six months since completing last therapy for CLL
•7. Have detectable MRD, as shown by peripheral blood or bone marrow involvement or have attained an MRD negative remission. The latter group is eligible for registration and three-monthly monitoring for MRD relapse

•1. Lymph nodes of 2 cm or greater in maximum diameter
•2. Known Human Immunodeficiency Virus (HIV) positive
•3. Active infection
•4. Past history of anaphylaxis following exposure to rat or mouse derived Commonly Deleted Region (CDR)-grafted humanised monoclonal antibodies
•5. Use of prior investigational agents within six weeks
•6. Pregnancy or lactation
•7. Central Nervous System (CNS) involvement with CLL
•8. Mantle cell lymphoma
•9. Other severe, concurrent diseases or mental disorders
•10. Active secondary malignancy
•11. Persisting severe pancytopenia due to previous therapy rather than disease (neutrophils <0.5 x 109/l or platelets <50 x 109/l)
•12. Patients previously treated with allogeneic Stem Cell Transplantation (SCT)
•13. Patients who previously failed alemtuzumab therapy

发起方

eeds Teaching Hospitals NHS Trust (UK)