EUCTR2015-001570-17-DK进行中（未招募）不适用
A Phase 2 study of the antibody-radionuclide-conjugate 177Lu-DOTA-HH1 (Betalutin™) in patients with CD37-positive relapsed follicular lymphoma
ordic Nanovector ASA0 个研究点目标入组 125 人开始时间: 2015年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
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. Histologically confirmed (by World Health Organization [WHO] classification) follicular lymphoma (follicular grade I-IIIA)
- •2. Relapsed after 2 or more prior systemic regimens
- •3. Requiring initiation of treatment for the NHL
- •4. Age =18 years
- •5. ECOG performance status of 0-2
- •6. Life expectancy of at least 3 months
- •7. Bone marrow tumour infiltration <25% tumour cells
- •8. CD37-positive; re-biopsy or test existing tumour material if not known
- •9. Negative HAMA test
- •10. Laboratory values within 15 days before study enrolment:
- •a) Absolute Neutrophil Counts = 1.5 x 109/l
- •b) Platelet count = 150 x 109 /l
- •c) Total bilirubin = 1.5 x upper limit of normal
- •d) Alkaline Phosphatase = 4x normal level
- •e) ALAT = 4x normal level
- •f) Creatinine =110 µmol/L (men), 90 µmol/L (women)
- •11. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (according to standard criteria: at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by CT scan).
- •12. Women of childbearing potential must:
- •a. understand that the study medication is expected to have teratogenic risk
- •b. have a negative serum pregnancy test at screening and before Betalutin injection
- •c. commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control with a Pearl-Index = 1%. without interruption, 4 weeks before starting study drug, throughout study drug therapy and for 5 months after end of study drug therapy, even if she has amenorrhoea
- •13. Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 5 months
- •14. The patient has been fully informed about the study and has signed the informed consent form
- •15. The patient is willing and able to comply with the protocol and agrees to return to the hospital for follow-up visits and examination
- •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 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. 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) Known to be HIV positive
- •c) Pulmonary conditions e.g. unstable or uncompensated respiratoryd) Hepatic conditions
- •e) Renal conditions
- •f) Neurological conditions
- •g) Psychiatric conditions
- •h) Metabolic conditions
- •i) History of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome
- •j) Cardiac conditions, including
- •i. History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks
- •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) in the past 24 weeks.
- •2. Bulky disease defined as the presence of one or more nodes with at least one dimension of 10 cm or more.
- •3. Ongoing immunosuppressive therapy, including systemic corticosteroids. Patients may be using topical or inhaled corticosteroids
- •4. Known or suspected central nervous system involvement of lymphoma
- •5. Previous total body irradiation, or irradiation of >25% of the patient’s bone marrow
- •6. Investigational drug, chemotherapy, or immunotherapy received within the last 4 weeks prior to start of study treatment, except for the pre-treatment used in this study
- •7. Pregnant or lactating women
- •8. Prior hematopoietic allogenic stem cell transplantation
- •9. Prior autologous stem cell transplantation =2 years ago
- •10. History of a non-lymphoma malignancy 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) localized prostate cancer
- •e) other adequately treated Stage 1 or 2 cancer currently in complete remission
- •f) or any other cancer that has been in complete remission for = 5 years
- •11. Allergy to X ray contrast agents
研究者
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