EUCTR2005-003949-14-DE进行中（未招募）不适用
Pilot study of bortezomib under rituximab standard therapy in patients with relapsed or refractory follicular lymphoma and at least 2 prior therapies
ORTHO BIOTECH, Geschäftsbereich der JANSSEN-CILAG GmbH0 个研究点目标入组 30 人开始时间: 2005年10月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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. Male and female patients aged between 18 and 70 years
- •2. Histologically established, relapsed/refractory follicular CD-20-positive myeloma
- •(grade I and 2), of stages III/IV (WHO) requiring treatment
- •3. Patients who are designed to be treated with rituximab after 2 or more cyto-
- •static pretreatments
- •4. Existence of patient’s written informed consent
- •5. Women must be either post-menopausal for 2 years minimum, hysterectomized,
- •or have had a tubal ligation; patients of childbearing potential must:
- •a) use a safe method of contraception during treatment and for 12 months after
- •completion (oral combination contraceptives, depot injections, implantates, IUDs
- •hormonal IUD acting as a combination of mechanical and hormonal contra-
- •ceptive), sexual abstinence, vasectomized partner)
- •b) have a negative pregnancy test at time of screening
- •6. Male patients must use a reliable method of contraception during treatment and
- •up to 12 months after completion. (Men who are planning to have children should
- •be offered the option of sperm cryopreservation.)
- •7. Karnofsky status of 60% or more
- •8. AST (S-GOT) or ALT (S-GPT) less than 2.5 times the upper limit of normal
- •9. Total bilirubin less than 1.5 times the upper limit of normal
- •10. Adequate haematological functions:
- •leukocytes 3.0 x 109/l or more
- •neutrophils 1.5 x 109/l or more
- •platelets 50 x 109/l or more
- •11. Creatinine less than 2 times the upper limit of normal
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Use of co-medication not allowed according to the SmPC
- •2. Previous treatment with bortezomib within the past 6 months before inclusion in
- •3. Previous treatment with a combination of rituximab and bortezomib
- •4. Known allergic reaction to bortezomib, boron, or mannitol
- •5. Life expectancy of less than 3 months
- •6. Malignant neoplasia (except basalioma) within the past 5 years
- •7. Peripheral neuropathy of CTC grade 2 or more
- •8. Other severe comorbidities which, in the attending physician’s opinion, preclude
- •involvement in the trial:
- •a) Hepatic or renal insufficiency; clinically relevant pulmonary or gastrointestinal
- •b) Cardiac failure > NYHA II; myocardial infarction within 6 months prior to
- •screening; pectoral angina; cardiac arrhythmia (more than Lown IVb); ECG
- •evidence of acute ischaemia; conduction disorders; cardiac amyloidosis
- •c) Systemic infection requiring treatment
- •d) Poorly controlled hypertension or other clinically relevant vascular conditions
- •e) Poorly controlled diabetes mellitus or other clinically relevant endocrine or meta-
- •bolic conditions
- •f) Pericardial disease
- •g) Acute diffuse infiltrative pulmonal diseases
- •9. Hypotension (RRsys seated = 100 mmHg and/or RRdia seated = 60 mmHg)
- •10. HIV-positive patients
- •11. Active hepatitis B and/or hepatitis C
- •12. Pregnant or breastfeeding patients
- •13. Unwillingness or unability to cooperate; foreseeable problems with follow-up;
- •psychiatric diseases; known current alcohol, drug, or substance abuse; legal
- •14. Concurrent involvement in other clinical trials, or involvement in another clinical
- •trial within 30 days prior to inclusion in this trial; exceptions are drug
- •examinations for the treatment of a relapse in the course of the treatment.
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