EUCTR2007-001103-37-DE进行中（未招募）不适用
An open-label, multicentre, non-randomised, dose-escalating phase I/II study, with a randomized phase II part, to investigate the safety and tolerability of RO5072759 given as monotherapy in patients with CD20+ malignant disease.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 134
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
- •Patients in the Phase I part of the study must meet the following criteria: 1. Have documented CD20+ malignant disease (B-cell lymphoma or B-CLL [B-CLL confirmed by NCI Working Group Criteria, 2008) for which no therapy of curative or high priority exists and for whom treatment with an anti-CD20 antibody may be appropriate. For each patient, a prior biopsy demonstrating CD20 positivity of tumour cells must be available locally prior to dosing, and will be further confirmed following central review (For B-CLL patients confirmation of CD20+ status must be performed by flow cytometry. Patients with small lymphocytic lymphoma [SLL], must have CD20+ status confirmed by histopathological evaluation of a lymph node biopsy). Ideally, where feasible during the course of the study, confirmation that the disease remains CD20+, should be obtained (Fine needle aspiration cytology [FNAC] is sufficient for this purpose where feasible). In addition, where available, the initial diagnostic biopsy will also be reviewed centrally. 2. Have either: • Relapsed or refractory indolent NHL • Relapsed or refractory aggressive NHL • Relapsed or refractory B-CLL 3. All patients (NHL and B-CLL) must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by computerized tomography [CT] scan). In addition, where appropriate, for CLL patients, circulating lymphoctye cell assessments will be performed. Note that all measurable and evaluable disease must be assessed and documented prior to initiation of RO5072759 treatment. Tumor response will be based on the status of all areas of disease. Patients in both Phase I and II parts of the study must also meet the following criteria to be eligible for study entry: 4. Able and willing to provide written informed consent and to comply with the study protocol. 5. Have a clinical indication for treatment as determined by the investigator 6. Age >18 years. 7. ECOG performance status of 0-2 8. Life expectancy >12 weeks
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •Patients in both Phase I and II portions who meet any of the following criteria at screening will be excluded from the study: 1. Prior use of any investigational monoclonal antibody therapy or other agent within 6 months of study start 2. Prior use of any anti-cancer vaccine 3. Prior use of standard anti-lymphoma/leukemia therapy or radiation therapy within 4 weeks of enrollment 4. Prior administration of rituximab within 56 days of study entry. However, for those patients with aggressive disease (DLBCL and MCL) and any other patient, where immediate treatment is mandated, a rituximab wash-out period of 28 days will be considered acceptable. This will be approved by the Sponsor on a case by case basis. 5. Prior administration of radioimmunotherapy 3 months prior to study entry 6. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Known sensitivity or allergy to murine products. 7. Central nervous system lymphoma 8. History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for =2 years prior to enrollment. 9. Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of symptomatic bronchospasm). 10. Known active bacterial, viral (including human immunodeficiency virus [HIV]), fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks of receiving the first dose of RO5072759 11. Recent major surgery (within 4 weeks prior to receiving first dose of RO5072759), other than for diagnosis. 12. Any of the following abnormal laboratory values: Renal – Calculated creatinine clearance by Cockcroft-Gault formula = 50 mL/min for NHL patients, or = 60 mL/min for the first 3 B-CLL patients enrolled in cohort 4b (See Appendix 5). The restriction of = 60 mL/min for the first 3 B-CLL patients, may be modified for subsequent cohorts (i.e., reduced or increased) based upon review of the ongoing safety data but the calculated creatinine clearance should not be = 50 mL/min. 13. Presence of positive test results for: - Human immunodeficiency virus (HIV), - Hepatitis B (HB virus [B DNA], HB surface antigen [HBsAg], total HB core antibody [anti-HB-c] - Hepatitis C (Hepatitis C virus [HCV] antibody serology testing. 14. Women who are pregnant or lactating. 15. Fertile men or women of childbearing potential unless (1) surgically sterile or (2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly. Effective contraception is required throughout the study and (because of the long half-life of humanized monoclonal antibodies and the potential for prolonged lymphopenia) for at least 12 months after the last dose of RO5072
研究者
相似试验
未知
1 期
Phase I/II study of OPB-31121 in patients with progressive hepatocellular carcinomaJPRN-jRCT2080221507Otsuka Pharmaceutical Co., Ltd.
尚未招募
1 期
An Open-Label, Multicenter, Non-Randomized, Dose-Escalation, Phase 1 Study to Evaluate Safety and Efficacy of Intravesical SN-38 Lipid Suspension in Patients with Non-Muscle Invasive Bladder CancerCTRI/2022/05/042539Intas Pharmaceuticals Ltd India
已完成
1 期
Bioequivalence study comparing felbamate tablets USP 600 mg of Emcure Pharmaceuticals Ltd., India to the Reference Listed Drug (RLD), Felbatol® (felbamate) 600 mg tablets manufactured by MEDA Pharmaceuticals Inc, USA in adult male and nonpregnant female epilepsy patients.CTRI/2015/08/006138Emcure Pharmaceuticals Ltd28
进行中（未招募）
1 期
A randomised, open-label, multi-centre, dose-finding study to evaluate cycle control of 15 mg or 20 mg estetrol combined with either 150 µg levonorgestrel or 3 mg drospirenone, compared to a combined oral contraceptive containing estradiol valerate and dienogest. - FIESTA studyOnly healthy premenopausal volunteers will participate in this clinical trial. Intended indication: contraception.MedDRA version: 12.1Level: LLTClassification code 10036556Term: PregnancyEUCTR2010-019865-26-FIEstetra S.A.
已完成
2 期
A clinical trial to study the efficacy and safety of different doses of bone marrow derived mesenchymal stem cells in patients with critical limb ischemia due to Buergers Disease (gangrene of foot)CTRI/2011/11/002107Stempeutics Research Pvt Ltd