EUCTR2019-004337-17-NL进行中（未招募）1 期
REtreatment with VEnetoclax and Acalabrutinib after venetoclax Limited duration (REVEAL) A prospective, multicenter, phase-II trial of venetoclax plus acalabrutinib in patients who have relapsed after first line venetoclax + anti-CD20 mAb treatment for chronic lymphocytic leukemia (CLL or SLL)
HOVON Foundation0 个研究点目标入组 60 人开始时间: 2020年6月30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
- 60
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 after at least (clinical) partial response as best response after the following initial study treatment: venetoclax-rituximab in HOVON 140/GAIA or venetoclax-obinutuzumab in HOVON 139/GIVE or HOVON 140/GAIA;
- •WHO/ECOG performance status 0-3, stage 3 only if attributable to CLL
- •Age at least 18 years;
- •Adequate BM function defined as:
- •-Hemoglobin >5 mmol/l or Hb > 8 g/dL
- •-Absolute neutrophil count (ANC) >0.75 x 109/L (750/µL), unless directly attributable to CLL infiltration of the BM, proven by BM biopsy
- •-Platelet count >30 x 109/L (30,000/µL) without transfusion and irrespective whether it is attributable to CLL infiltration in the BM;
- •Estimated Glomerular Filtration Rate (eGFR) (MDRD) or estimated creatinine clearance (CrCl = 30ml/min (Cockcroft-Gault appendix E);
- •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 upper limit of normal (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 (HBV) (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 anti-HBc or hepatitis C antibody may be included if they have a negative PCR within 6 weeks before enrollment. Those who are PCR positive will be excluded;
- •Please note: For patients positive for anti-HBc HBV-DNA PCR has to be repeated every month until 12 months after last dose of study treatment.
- •Patient is able and willing 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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Any prior therapy with BTK inhibitor;
- •Prior treatment with venetoclax other than first line;
- •Other therapy with exception of chemo-/immunotherapy which is allowed also after venetoclax first line relapse;
- •Transformation of CLL (Richter’s transformation);
- •Patient with a history of confirmed progressive multifocal leukoencephalopathy (PML);
- •Malignancies other than CLL currently requiring systemic therapy or not treated in
- •curative intention or showing signs of progression after curative treatment;
- •Known allergy to xanthine oxidase inhibitors and/or rasburicase;
- •History of drug-specific hypersensitivity or anaphylaxis to any study drug (including active product or excipient components);
- •Active bleeding or history of bleeding diathesis (e.g. hemophilia or von Willebrand disease);
- •Active fungal, bacterial, and/or viral infection that requires systemic therapy;
- •Please note: active controlled as well as chronic/recurrent infections are at risk of reactivation/infection during treatment;
- •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/inducer or anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K
- •antagonists;
- •Please note: Patients being treated with DOACs apixaban, edoxaban or rivaroxaban can be included, but must be properly informed about the potential risk of bleeding under treatment with acalabrutinib.
- •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, myocardial infarction within 6 months) (CTCAE grade III-IV);
- •Severe pulmonary dysfunction (CTCAE grade III-IV);
- •Severe neurological or psychiatric disease (CTCAE grade III-IV);
- •Patient who has difficulty with or are unable to swallow oral medication, or have significant gastrointestinal disease that would limit absorption of oral medication;
- •Vaccination with live vaccines within 28 days prior to registration;
- •Use of any other experimental drug or therapy within 28 days of 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 or 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; (2) willing to use a highly effective contraceptive method during study treatment and for 30 days after end of treatment;
- •Current participation in other clinical trial (other than follow up HOVON139/HOVON140);?
- •Any psychological, familial, sociological and geographical condition potentially hampering
- •compliance with the study protocol and follow-up schedule.
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