EUCTR2019-002528-34-DK进行中（未招募）1 期
First line treatment with VeNEtoclaX and ibruTinib induction followed by obinutuzumab intenSificaTion Exclusively in CLL/SLL Patients not in complete remission and/or with detectable bone marrow minimal residual disease (NEXT STEP trial)
HOVON Foundation0 个研究点目标入组 85 人开始时间: 2020年11月25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
- 85
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
- •Documented CLL or SLL requiring treatment according to IWCLL criteria, including minimal required markers (CD5/CD19/CD23 triple positive with light chain restriction);
- •WHO performance status 0-3 stage 3 only if attributable to CLL/SLL;
- •No prior treatment for CLL/SLL;
- •Age at least 18 years;
- •Adequate BM function defined as:
- •- Hb > 5 mmol/l or Hb > 8 g/dL
- •- Absolute neutrophil count (ANC) = 0.75 x 109/L or 750/µL
- •- Platelet count = 50 x 109/L or 50,000 /µL
- •Unless directly attributable to CLL/SLL infiltration of the BM, proven by BM biopsy;
- •Estimated Glomerular Filtration Rate (eGFR) (MDRD) or estimated creatinine clearance (CrCl) = 30 l/min (Cockcroft-Gault );
- •Please note: in case eGFR or CrCl is <50ml/min the patient needs to be considered high risk for TLS
- •Adequate liver function as indicated:
- •- Serum aspartate transaminase (ASAT) and alanine transaminase (ALAT) = 3.0 x ULN
- •- Bilirubin =1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin);
- •Prothrombin time (PT)/International normal ratio (INR) <1.5 x ULN and activated partial thromboplastin time (aPTT) <1.5 x ULN;
- •Negative serological testing for hepatitis B virus (Hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) negative) and hepatitis C virus (hepatitis C antibody). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment. Those who are PCR positive will be excluded;
- •Ability and willingness to adhere to the study visit schedule and other protocol requirements;
- •Patient is capable of giving informed consent;
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •Transformation of CLL (Richter’s transformation);
- •Malignancies other than CLL/SLL currently requiring systemic therapy or not being treated incurative intention before or showing signs of progression after curative treatment;
- •Patient with CNS involvement
- •Known allergy to xanthine oxidase inhibitors and/or rasburicase;
- •Intolerance of exogenous protein administration;
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Known sensitivity or allergy to murine products;
- •Active fungal, bacterial, and/or viral infection that requires systemic therapy;
- •Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled: infection, auto-immune hemolysis, immune thrombocytopenia, diabetes, hypertension, hyperthyroidism or hypothyroidism etc.);
- •Patient known to be HIV-positive;
- •Patient requiring treatment with a strong cytochrome P450 (CYP) 3A inhibitor or anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K antagonists;
- •History of stroke or intracranial hemorrhage within 6 months prior to registration;
- •Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive
- •heart failure or symptomatic ischemic heart disease) (CTCAE grade III-IV);
- •Severe pulmonary dysfunction (CTCAE grade III-IV);
- •Patient with Child Pugh C
- •Severe neurological or psychiatric disease (CTCAE grade III-IV);
- •Vaccination with live vaccines within 28 days prior to registration;
- •Use of any other experimental drug or therapy within 28 days prior to registration
- •Major surgery within 28 days prior to registration;
- •Steroid therapy within 10 days prior to registration, with the exception of inhaled steroids for
- •asthma, topical steroids, steroids up to 20 mg of dose equivalents of prednisolone daily to control autoimmune phenomenon’s, or replacement/stress corticosteroids;
- •Pregnant women and nursing mothers.;
- •Fertile men or women of childbearing potential unless: (1). surgically sterile or = 2 years after the onset of menopause, and/or (2) willing to use a highly effective contraceptive method such as oral contraceptives, intrauterine device, sexual abstinence or barrier method of contraception in conjunction with spermicidal jelly during study treatment and in female patients for 3 months after end of induction treatment and 18 months after end of treatment with obinutuzumab and male patients for 6 months after end of treatment ; ?
- •Current participation in other clinical trial;
- •Any psychological, familial, sociological and geographical condition potentially hampering
- •compliance with the study protocol and follow-up schedule.
研究者
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