NL-OMON55476已完成2 期
A phase I/II study of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) antibody-radionuclide-conjugate for treatment of relapsed non-Hodgkin lymphoma. - LYMRIT-37-01 (3185/0002)
ordic Nanovector ASA0 个研究点目标入组 1 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria: PART B (phase IIb) , 1. Histologically confirmed (by WHO
- •classification) relapsed non-Hodgkin B-cell FL (grade I-IIIA).
- •2. Male or female aged >= 18 years.
- •3. Received at least 2 prior systemic anti-neoplastic or
- •immunotherapy-based regimens (maintenance therapy following a CR/PR is not
- •considered to be a separate line of therapy). Systemic regimens including
- •agents such as idelalisib or other PI3K inhibitors qualify as a prior line of
- •4. Prior therapy must have included a rituximab/anti-CD20 agent and an
- •alkylating agent which may be been administered in separate regimens.
- •5. Patients must be refractory to any at least one previous regimen that
- •contained rituximab or an anti-CD20 agent, with refractoriness defined as:
- •i. no response (no CR or PR) during therapy, or
- •ii. a response (CR/PR) lasting less than 6 months after the completion of a
- •regimen of rituximab/anti-CD20 therapy (including occurrence of progressive
- •disease (PD) during rituximab/anti-CD20 maintenance therapy, or within 6 months
- •of completion of maintenance therapy).
- •6. WHO performance status of 0-2.
- •7. Life expectancy of >= 3 months.
- •8. Bone marrow tumour infiltration < 25% (in biopsy taken from a site not
- •previously irradiated).
- •9. Measurable disease by CT or MRI: longest diameter (LDi) > 1.5 cm for nodal
- •lesion, LDi > 1.0 cm for extra nodal lesion on an assessment performed during
- •the screening period.
- •Criteria 10 and 11 must be satisfied within 72 hours of the administration of
- •10. ANC >= 1.5 x 109/L.
- •11. Platelet count >= 100 x 109/L.
- •Criteria 12 to 15 must be verified at time of eligibility review within 2 weeks
- •prior to rituximab administration:
- •12. Haemoglobin >= 9.0 g/dL.
- •13. Total bilirubin <=1.5 x upper limit of normal (ULN) (except patients with
- •documented Gilbert*s syndrome [< 3.0 mg/dL]).
- •14. Liver enzymes: Aspartate transaminase (AST); Alanine transaminase (ALT) or
- •ALP <= 2.5 x ULN (or <= 5.0 x ULN with liver involvement by primary disease).
- •15. Adequate renal function as demonstrated by a serum creatinine < 1.5 x ULN.
- •16. Women of childbearing potential must:
- •a) understand that the study medication is expected to have teratogenic risk.
- •b) have a negative serum beta human-chorionic gonadotropin (ß-HCG) pregnancy
- •test at screening.
- •c) commit to continued abstinence from heterosexual intercourse (excluding
- •periodic abstinence or the withdrawal method) or begin a highly effective
- •method of birth control with a Pearl-Index < 1%, without interruption, from 4
- •weeks before starting study medication, throughout study medication therapy and
- •for 12 months after end of study medication therapy, even if she has
- •amenorrhoea. Apart from abstinence, highly effective methods of birth control
- •i. Combined (oestrogen and progestogen containing) hormonal contraception
- •associated with inhibition of ovulation (oral, intravaginal, transdermal).
- •ii. Progestogen-only hormonal contraception associated with inhibition of
- •ovulation ((oral, injectable, implantable)
- •iii. Intrauterine device (IUD).
- •iv. Intrauterine hormone-releasing system (IUS).
- 另有 4 项未显示
排除标准
- •Exclusion Criteria: PART B (phase IIb),
- •1. Prior hematopoietic allogenic stem cell transplantation.
- •2. Patients with a prior autologous stem cell transplanted (SCT) are excluded
- •unless at least two years have elapsed since transplantation.
- •3. Evidence of histological transformation from FL to diffuse large B-cell
- •lymphoma (DLBCL) at time of screening (transformation to grade IIIB that was
- •successfully treated with recurrence of grade I-IIIA initial clone is
- •4. Previous total body irradiation.
- •5. Prior anti-lymphoma therapy (chemotherapy, immunotherapy or other systemic
- •agent including any investigational agent) within 4 weeks prior to start of
- •study treatment (corticosteroid treatment at doses of <= 20 mg/day, topical or
- •inhaled corticosteroids, granulocyte colony-stimulating factor [G-CSF] or
- •granulocyte-macrophage colony-stimulating factor [GM-CSF] are permitted up to 2
- •weeks prior to start of rituximab).
- •6. Patients who are receiving any other investigational medicinal products.
- •7. Patients with known or suspected CNS involvement of lymphoma.
- •8. History of malignancy other than FL within 5 years prior to screening,( i.e.
- •patients with cancer diagnosed within 5 years prior to screening or who were
- •diagnosed prior to 5 years and were not in CR or were on treatment within 5
- •years prior to screening), with the exception of malignancies with a negligible
- •risk of metastasis or death (e.g. 5-year OS rate >90%), such as adequately
- •treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localised
- •prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
- •9. Pregnant or breastfeeding women.
- •10. Exposure to another CD37 targeting drug.
- •11. A known hypersensitivity to rituximab, lilotomab, Betalutin or murine
- •proteins or any excipient used in rituximab, lilotomab, or Betalutin.
- •12. Has received a live-attenuated vaccine within 30 days prior to enrolment.
- •13. 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
- •f. Cardiac conditions in the previous 24 weeks (before date of consent),
- •i. history of acute coronary syndromes (including unstable angina).
- •ii. class II, III, or IV heart failure as defined by the New York Heart
- •Association (NYHA) functional classification system.
- •iii. known uncontrolled arrhythmias (except sinus arrhythmia).
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