NL-OMON54803招募中2 期
A prospective, open-label, multicenter randomized phase-II trial to evaluate the efficacy and safety of a sequential regimen of Gazyvaro (obinutuzumab) followed by obinutuzumab and venetoclax, followed by either standard venetoclax maintenance or MRD guided venetoclax maintenance in first-line patients with CLL and unfit for FCR-like regimens. (GIVE trial) - HOVON 139 C
HOVO0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Diagnosis of symptomatic CLL (according to IWCLL guidelines);
- •- Patients without prior treatment for CLL (Corticoid treatment administered
- •due to necessary immediate intervention is allowed; within the last 10 days
- •before start of study treatment only dose equivalents of max 20 mg prednisolone
- •are permitted);
- •- Patients aged >= 18 years, not fit for FCR-like regimens;
- •- Able to adhere to the study visit schedule and other protocol requirements;
- •- WHO performance status of <= 2;
- •- Laboratory test results within these ranges:
- •- absolute neutrophil count >= 1.0 x 109/l and platelet count >= 50 x 109/l
- •unless due to bone marrow infiltration,
- •- creatinine clearance >= 45 ml/min,
- •- total bilirubin 1,5 x ULN unless considered due to Gilbert*s syndrome,
- •- transaminases <= 3 x ULN;
- •-Negative serum or urine pregnancy test within 28 days prior to registration
- •(all females of childbearing potential) ;
- •- Written informed consent
- •- Patient is capable of giving informed consent
排除标准
- •- Current inclusion in other clinical trials
- •- 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
- •- Positive hepatitis serology (serology testing required at screening), as
- •- Hepatitis B virus (HBV): Patients with positive serology for hepatitis B
- •defined as positivity for
- •hepatitis B surface antigen (HBsAg) or hepatitis B core antibody
- •(anti-HBc).
- •- Hepatitis C virus (HCV): Patients with positive hepatitis C serology
- •unless HCV- (RNA) is
- •confirmed negative.
- •- HIV positive patients;
- •- • Active fungal, bacterial, and/or viral infection that requires systemic
- •- Vaccination with a live vaccine a minimum of 28 days prior to registration.
- •- Use of any other experimental drug or therapy within 28 days of baseline;
- •- Concurrent use of other anti-cancer agents or treatments;
- •- History of prior malignancy, except for conditions as listed below if
- •patients have recovered from the acute side effects incurred as a result of
- •previous therapy:
- •- Malignancies surgically treated with curative intent and with no known
- •active disease present for 3 years before randomization
- •- Adequately treated non-melanoma skin cancer or lentigo maligna without
- •evidence of disease
- •- Adequately treated cervical carcinoma in situ without evidence of disease
- •- Severe cardiovascular disease (arrhythmias requiring chronic treatment,
- •congestive heart failure or symptomatic ischemic heart disease) (CTCAE grade
- •- Severe pulmonary dysfunction (CTCAE grade III-IV);
- •- Severe neurological or psychiatric disease (CTCAE grade III-IV);
- •- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled
- •diabetes, hypertension, hyperthyroidism or hypothyroidism , etc.)
- •- Women who are pregnant or lactating
- •- 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 (Pearl Index <1) during study treatment and in
- •female patients for 18 months after end of antibody treatment and male patients
- •for 6 months after end of treatment.
- •- Any psychological, familial, sociological and geographical condition
- •potentially hampering compliance with the study protocol and follow-up
研究者
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