A prospective, multi-center phase II study of subcutaneous alemtuzumab combined with oral dexamethasone, followed by alemtuzumab maintenance or allogeneic stem-cell transplantation, in chronic lymphocytic leukemia which is associated with 17p deletion or is refractory to fludarabine. - CLL2O Protocol of the German CLL Study Group (GCLLSG)

niversitätsklinikum Ulm0 个研究点目标入组 95 人开始时间: 2008年4月9日最近更新: 2012年3月19日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 95

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•The following criteria are to be checked at the time of study entry. The patient may only be included if all of the following statements are true:
•1. The patient has CLL requiring treatment (Binet C or A/B with active disease” according to the NCI criteria).
•2.One or both of the following is true:
•The patient's disease is refractory to any previous fludarabine-containing regimen, defined as no CR or PR according to NCI criteria, or progression within 6 months after any fludarabine-containing regime. (N.B.: Within the framework of this trial, the term fludarabine-refractory” is synonymous to a refractory status to any established purine analogue (i.e. pentostatin, cladribine).)
•17p deletion is present (irrespective of whether previously treated or untreated).
•3. The patient is at least 18 years of age.
•4. The patient's performance status is 0, 1 or 2 on the WHO/ECOG scale.
•5. Any previous chemotherapy and/or immunotherapy ended at least four weeks before the first study treatment with alemtuzumab.
•6. The patient has recovered from all previous chemotherapy and/or immunotherapy.
•7. For fertile men and for women of childbearing potential: Adequate contraception (oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
•8. The patient has given written informed consent to participate in the study.
•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

排除标准

•The following criteria are to be checked at the time of study entry. The patient must be excluded if any one (or more) of the following statements is true:
•1. The patient has received more than five different prior therapeutic regimens.
•2.Any major organ dysfunction is present (e.g. unstable angina pectoris, NYHA III/IV heart insufficiency, significant coronary stenoses, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary disease with hypoxemia, renal failure).
•3. Any of the following laboratory values are found at the screening visit to be >2x the upper limit of the normal range: serum creatinine, serum bilirubin, ASAT, ALAT.
•4. Any active infection is present.
•5. B-PLL or Richter transformation is diagnosed or suspected (symptoms or cytology).
•6. There is involvement of the central nervous system.
•7. The patient is known to be positive for human immunodeficiency virus (HIV).
•8. CMV viremia is present, as demonstrated by pp65 EA or CMV-DNA.
•9. The patient has previously been treated with alemtuzumab.
•10. The patient has received autologous or allogeneic SCT within the past six months.
•11. The patient is receiving long-term systemic treatment with corticosteroids or has received such treatment in the four weeks before first treatment with alemtuzumab.
•12. Any additional active malignancy is present.
•13. The patient has ever had an anaphylactic response to humanized antibodies.
•14. For female patients: The patient is pregnant or lactating.
•15. The patient has a history of drug or alcohol abuse that might lead to inability to comply with the protocol.

研究者

发起方

niversitätsklinikum Ulm

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