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临床试验/EUCTR2011-000033-36-CZ
EUCTR2011-000033-36-CZ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: 2014年8月5日最近更新:
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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
200
研究概览入排标准研究者记录与标识符相似试验

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 Pharmacokinetics Cohort):
  • •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.
  • •Part B (FL 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 therapy.
  • •4. Prior therapy must have included 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 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 pr

排除标准

  • •Part A 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 <150x109/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 bilitubin > 1.5xULN (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 >2.5xULN (or >5.0xULN with liver involvement by primary disease). (Part C only).
  • •e. Creatinine = 115 µmol/l (men), 97 µmol/l (women) (Part A only).
  • •Serum creatinine =1.5xULN (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.
  • •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 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, localized prostate cancer, ductal ca

研究者

发起方
ordic Nanovector ASA

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