EUCTR2013-001088-22-DE进行中（未招募）1 期
A PROSPECTIVE, MULTICENTER, PHASE-II TRIAL EVALUATING EFFICACY AND SAFETY OF BENDAMUSTINE + GA101 (BG) IN PATIENTS WITH RELAPSED CLL FOLLOWED BY MAINTENANCETHERAPY WITH GA101 FOR RESPONDING PATIENTS. - CLLR3
Städtisches Klinikum München GmbH0 个研究点目标入组 58 人开始时间: 2014年4月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
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
- •1. Diagnosis of CLL in need of treatment according to the iwCLL guidelines 8
- •2. Relapsed or refractory disease after at least one, but no more than 3 prior regimens for CLL
- •3. Medically fit patients without relevant comorbidity, defined as total CIRS score =6 (single score < 4 for one organ category)
- •4. ECOG performance status of 0 - 2
- •5. Hematology values within the following limits unless cytopenia is caused by the underlying disease, i.e. no evidence of additional bone marrow dysfunction (e.g. myelodysplastic syndrome (MDS), hypoplastic bone marrow due to toxicity of prior therapy):
- •a. Absolute neutrophil count =1.5 x 109/L
- •b. Platelets =50 x 109/L and more than 7 days since last transfusion
- •6. Creatinine clearance >60 ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured after 24 h urine collection
- •7. Adequate liver function as indicated by a total bilirubin, AST, and ALT =2 the institutional ULN value, unless directly attributable to the patient’s CLL
- •8. Negative serological Hepatitis B test (i.e. HBsAg negative and anti-HBc negative, patients positive for anti-HBc may be included if PCR for HBV DNA is negative); negative testing of Hepatitis C RNA; negative HIV test within 6 weeks prior to registration
- •9. 18 years of age or older
- •10. Life expectancy >6 months
- •11. Able and willing to provide written informed consent and to comply with the study protocol procedures
- •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 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
排除标准
- •1. Detected del817p) or TP53 mutation
- •2. Refractoriness to FCR/BR
- •3. Transformation of CLL to aggressive NHL (Richter’s transformation)
- •4. Known central nervous system (CNS) involvement
- •5. Evidence of significant uncontrolled concomitant disease
- •6. Major surgery < 30 days before screening
- •7. Decompensated hemolytic anemia 28 days before screening
- •8. Hemolytic cystitis 28 days before screening
- •9. Patients with a history of confirmed PML
- •10. Prior treatment with GA101
- •11. History of prior malignancy, except for conditions as listed below (a-d) and if patients have recovered from the acute side effects incurred as a result of previous therapy:
- •a. Malignancies treated with curative intent and with no known active disease present for = 2 years before randomization
- •b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease at screening
- •c. Adequately treated cervical carcinoma in situ without evidence of disease at screening
- •d. Surgically adequately treated low grade, early stage localized prostate cancer without evidence of disease at screening
- •12. Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks before registration
- •13. Patients with active infection requiring systemic treatment
- •14. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies and/ or known sensitivity or allergy to murine products
- •15. Hypersensitivity to fludarabine, cyclophosphamide, bendamustine, GA101 and/ or to any of the excipients for example mannitol
- •16. An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive an intensive therapy for CLL
- •17. Legal incapacity
- •18. Women who are pregnant or lactating
- •19. Fertile men or women of childbearing potential unless:
- •a. surgically sterile or =2 years after the onset of menopause
- •b. willing to use a highly effective contraceptive method (Pearl Index <1) during study treatment and for 12 months after end of study treatment
- •20. Vaccination with a live vaccine within a minimum of 28 days before screening
- •21. Participation in any other clinical trial which would interfere with study drug
- •22. Prisoners or subjects who are institutionalized by regulatory or court order
- •23. Persons who are in dependence to the sponsor or an investigator
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