NCT02657447撤回1 期
A Phase 1, Open Label, Randomized Study to Assess Pharmacokinetics, Biodistribution and Radiation Dosimetry of Lutetium (177Lu) Lilotomab Satetraxetan (Betalutin®) Radioimmunotherapy in Patients With Relapsed Non-Hodgkin Lymphoma
Nordic Nanovector1 个研究点 分布在 1 个国家开始时间: 2017年12月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Dosimetry
研究概览
简要总结
This study is a phase I, open label, randomized study to assess pharmacokinetics, biodistribution and radiation dosimetry of lutetium (177Lu) lilotomab satetraxetan (Betalutin®) radioimmunotherapy in patients with relapsed non-Hodgkin lymphoma. The study will also investigate the safety, toxicity and efficacy of Betalutin and pre-dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed (by WHO classification) relapsed indolent non-Hodgkin B-cell lymphoma of following subtypes: Follicular lymphoma (follicular grade I-IIIA), Marginal zone lymphoma (exclusion of MZL if large lymphocytes > 50%), Small lymphocytic lymphoma, Lymphoplasmacytoid and classical mantle cell lymphoma (no blastoid MCL).
- •Requiring initiation of treatment for the NHL.
- •Relapsed after at least one line of therapy including rituximab combination chemotherapy regimen.
- •Exhausted and/or ineligible for all standard treatment options.
- •Not a candidate for an autologous or allogeneic stem cell transplantation. Patients in progression after successful stem cell collection before before high-dose therapy and autologous stem cell transplantation may be considered for enrolment.
- •Age ≥ 18 years..
- •A pre-study ECOG performance status of 0-
- •In selected patients an ECOG score of 3 can be acceptable if it is clearly lymphoma-associated at the discretion of the investigator.
- •Life expectancy should be ≥ 3 months.
- •< 25% tumour cells in bone marrow biopsy prior to lilotomab/Betalutin treatment (biopsy taken from a site not previously irradiated).
- •All patients must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by CT scan). Patients without such a target lesion can be accepted on an individual basis if histological organ involvement can be evaluated for response e.g. involvement of the skin or the gastrointestinal tract.
- •Women of childbearing potential must:
- •have a negative serum pregnancy test at screening and before Betalutin injection
- •understand that the study medication is expected to have teratogenic risk
- •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, 4 weeks before starting study drug, throughout study drug therapy and for 12 months after end of study drug therapy, even if she has amenorrhoea.
- •Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
- •Patients previously treated with native rituximab are eligible.
- •The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination.
- •The patient has been fully informed about the study and has signed the informed consent form.
- •Negative HAMA test.
- •CD37 positive, re-biopsy or test on existing tumour material if not known
排除标准
- •Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, steroid requiring asthma/allergy, known HIV positive.
- •Laboratory values during screening :
- •Absolute Neutrophil Counts (ANC) ≤ 1.5 x 109 /l
- •Platelet count ≤ 150 x 109 /l
- •Total bilirubin ≥ 30 mmol/l
- •ALP and ALAT ≥ 4x normal level
- •GFR < 60 ml/min/1.73 m2 as measured by the CKD-EPI method.
- •Known or suspected CNS involvement of lymphoma
- •Previous total body irradiation, or irradiation of > 25% of the patient's bone marrow.
- •Chemotherapy, immunotherapy or another investigational drug received within the last 4 weeks prior to the patient entering screening.
- •Earlier treatment with radioimmunotherapy.
- •Exposure to another CD37 targeting drug.
- •Concurrent participation in another therapeutic treatment trial.
- •Previous hematopoietic stem cell transplantation (autologous and allogenic).
- •Pregnant or lactating women.
- •Transformed or potentially transformed NHL from indolent to aggressive
- •Receipt of live, attenuated vaccine within 30 days prior to enrolment
- •Test positive for hepatitis B (HBsAg and anti-HBc)
- •A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any excipient used in rituximab, HH1 or Betalutin
- •Malignant disease, other than that being treated in this study. Exceptions include: malignancies that were treated curatively and have not recurred within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancers; completely resected carcinoma in situ of any type.
研究组 & 干预措施
Arm 1: Betalutin with lilotomab dose 1
Experimental
Betalutin 15 MBq/kg b.w. with lilotomab pre-dosing
干预措施: Betalutin with lilotomab dose 1 (Drug)
Arm 2: Betalutin with lilotomab dose 2
Experimental
Betalutin 15MBq/kg b.w. with lilotomab pre-dosing
干预措施: Betalutin with lilotomab dose 2 (Drug)
结局指标
主要结局
Dosimetry
时间窗: 3 weeks
Estimation of individual tumour/organ uptake and retention of radioactivity.
次要结局
- The number of participants with adverse events as assessed by NCTCAE.(12 weeks)
- Lilotomab pharmacokinetics(3 weeks)
- Efficacy (Best overall response rate)(3 months - 1 year)
研究者
研究点 (1)
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