EUCTR2011-000033-36-DK进行中（未招募）1 期
A phase I/II study of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) antibody-radionuclide-conjugate for treatment of relapsed non-Hodgkin lymphoma.
ordic Nanovector ASA0 个研究点目标入组 200 人开始时间: 2018年1月31日最近更新:
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
- 200
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
- •Part A (phase I and phase IIa) and Part C (phase IIa Pharmacokinetic
- •1. Histologically confirmed (by WHO classification) relapsed incurable non-Hodgkin B-cell lymphoma of following subtypes; follicular grade I-IIIA (for Part C, this excludes patients meeting Part B criteria, who should enter Part B), marginal zone, small lymphocytic, lymphoplasmacytic, mantle cell.
- •2. Age = 18 years.
- •3. Part A: A pre-study WHO performance status of 0-1; Part C: WHO performance status of 0-2.
- •4. Life expectancy should be = 3 months.
- •5. <25% tumour cells in bone marrow biopsy (biopsy taken from a site not previously irradiated).
- •6. Measurable disease by radiological methods.
- •7. Women of childbearing potential must:
- •a) understand that the study medication is expected to have teratogenic risk.
- •b) have a negative pregnancy test.
- •c) agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy and for 12 months after end of study medication therapy, even if she has amenorrhoea.
- •8. Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
- •9. Patients previously treated with native rituximab are eligible.
- •10. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination.
- •11. The patient has been fully informed about the study and has signed the informed consent form.
- •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 therapy.
- •4. Prior therapy must have included rituximab/anti-CD20 agent and an alkylating agent – which may be been administered in separate
- •5. Patients must be refractory 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 including 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 rituximab:
- •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 demon
排除标准
- •Part A (phase I and phase IIa) and Part C (phase IIa Pharmacokinetic Cohort)
- •1. Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, uncontrolled asthma/allergy requiring systemic steroids, known HIV positive
- •2. Laboratory values within 15 days pre-registration:
- •a. Absolute Neutrophil Counts (ANC) = 1.5 x 109 /l
- •b. Part A: Platelet count = 150 x 109 /L. Part C: Platelet count <150×109/L
- •For Part C, criteria 2a and 2b must be satisfied within 72 hours of the administration of rituximab
- •c. Total bilirubin = 30 mmol/l (Part A only)
- •Total bilirubin > 1.5×ULN (except patients with documented Gilbert's syndrome [=3.0 mg/dL]) (Part C only)
- •d. ALP and ALAT = 4x normal level (Part A only)
- •Aspartate transaminase (AST), ALT or ALP >2.5×ULN (or >5.0×ULN with liver involvement by primary disease) (Part C only)
- •e. Creatinine = 115 µmol/l (men), 97 µmol/l (women) (Part A only)
- •Serum creatinine =1.5×ULN (Part C only)
- •f. Haemoglobin <9.0 g/dL (Part C only)
- •3. Known CNS involvement of lymphoma
- •4. Previous total body irradiation
- •5. Positive test for HAMA at screening
- •6. Chemotherapy or immunotherapy received within the last 4 weeks prior to start of study treatment. Pre-treatment with rituximab is allowed
- •7. Pregnant or lactating women
- •8. Previous hematopoietic stem cell transplantation (autologous and allogenic)
- •9. Part A: Previous treatment with radioimmunotherapy. Part C: Not applicable
- •10. Actively participating in another study or received an investigational drug within 4 weeks prior to enrolment
- •11. Receipt of live, attenuated vaccine within 30 days prior to enrolment
- •12. Part A and Part C: Test positive for hepatitis B (HBsAg and anti-HBc). Part C only: Test positive for hepatitis C and HIV
- •13. A known hypersensitivity to rituximab, lilotomab, Betalutin or murine proteins or any excipient used in rituximab, lilotomab or Betalutin
- •Part B (FL 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 accepted)
- •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 granulocytemacrophage 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
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