EUCTR2017-004506-18-NO进行中（未招募）1 期
A phase 2 open-label study of Betalutin in combination with rituximab in patients with relapsed/refractory follicular lymphoma (Archer-1)
ordic Nanovector ASA0 个研究点目标入组 25 人开始时间: 2018年1月2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
- 25
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. Patient must be = 18 years at the time of signing the informed consent
- •2. A pre-study ECOG performance status of 0-2
- •3. Histologically confirmed diagnosis (by 2008 WHO classification) of indolent non-Hodgkin B-cell follicular lymphoma (grade 1, 2 or 3a)
- •4. At least one (but not more than 3) prior regimens with an anti-CD20 antibody (alone or in combination with chemotherapy), with documented relapsed, refractory disease (must not be anti-CD20 antibody-refractory) or PD
- •5. Presence of at least one bi-dimensionally measurable lesion by CT: longest diameter (LDi) >1.5 cm for a nodal lesion; LDi >1.0 cm for an extranodal lesion within 28 days prior to start of treatment
- •6. Normal organ and bone marrow function defined as:
- •a. Absolute neutrophil count =1.5 x 10*9/L;
- •b. Platelet count =150 x 10*9/L;
- •c. Haemoglobin =9 g/dL;
- •d. Total bilirubin =1.5 x upper limit of normal (ULN) (except patients with documented Gilbert’s syndrome [< 3.0 mg/dL]);
- •e. Liver enzymes: Aspartate transaminase (AST); Alanine transaminase (ALT) or Alkaline phosphatase (ALP) =2.5 x ULN (or = 5.0 x ULN if liver involvement by primary disease);
- •f. Adequate renal function as demonstrated by a serum creatinine <1.5 x ULN;
- •7. Bone marrow involvement by lymphoma <25%
- •8. Life expectancy >3 months
- •9. Negative hepatitis B, hepatitis C and HIV screening tests
- •10. Negative ADA test at screening for lilotomab/Betalutin
- •11. Women of childbearing potential (see Protocol Appendix 3) must:
- •a. have a negative serum pregnancy test at screening and before Betalutin injection
- •b. understand that the study medication is expected to have teratogenic risk
- •c. agree to use, and be able to comply with, highly effective method of birth control with a Pearl Index = 1%.
- •Contraception is required without interruption, from 4 weeks before starting study drug, throughout study drug therapy and for 12 months after end of study drug therapy, even if she has amenorrhea
- •12. Male patients must agree to use condoms (See Protocol Appendix 3) during intercourse throughout study drug therapy and the following 12 months
- •13. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination
- •14. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •1. Previous haematopoietic stem cell transplantation (autologous and allogenic)
- •2. Evidence of histological transformation from FL to DLBCL at time of screening.
- •3. Previous total body irradiation
- •4. Chemotherapy, immunotherapy, radioimmunotherapy, or investigational therapy within 28 days before the start of study drug treatment (corticosteroid treatment at doses of = 20 mg/day, topical or inhaled corticosteroids, G-CSF or GM CSF are permitted up to 2 weeks prior to start of study treatment) or failure to recover from adverse events (AEs) associated with prior treatment
- •5. Patients who are receiving any other investigational medicinal products
- •6. Known or suspected central nervous system (CNS) involvement of lymphoma
- •7. History of a previous treated cancer except for the following:
- •a. adequately treated local basal cell or squamous cell carcinoma of the skin
- •b. cervical carcinoma in situ
- •c. superficial bladder cancer
- •d. localised prostate cancer undergoing surveillance or surgery
- •e. localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy
- •f. other adequately treated Stage 1 or 2 cancer currently in CR
- •8. Pregnant or lactating women (See Protocol Appendix 3)
- •9. Exposure to another CD37 targeting drug
- •10. A known hypersensitivity to RTX, lilotomab, Betalutin or murine proteins or any excipient used in rituximab, lilotomab, or Betalutin
- •11. Receipt of live, attenuated vaccine within 30 days prior to enrolment
- •12. Evidence of severe or uncontrolled systemic diseases:
- •a. Uncontrolled infection including evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment
- •b. Pulmonary conditions e.g. unstable or uncompensated respiratory disease
- •c. Hepatic, renal, neurological, or metabolic conditions - which in the opinion of the investigator would compromise the protocol objectives
- •d. Psychiatric conditions e.g. patients unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the study
- •e. History of erythema multiforme, toxic epidermal necrolysis, or Stevens Johnson syndrome
- •f. Cardiac conditions, including:
- •i. history of acute coronary syndromes (including unstable angina)
- •ii. class II, III, or IV heart failure as defined by the NYHA functional classification system
- •iii. known uncontrolled arrhythmias (except sinus arrhythmia) in the past 24 weeks
研究者
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