EUCTR2011-005150-62-FR进行中（未招募）不适用
A Phase Ib/II study of OBINUTUZUMAB combined with LENALIDOMIDE for the treatment of relapsed/refractory follicular and Aggressive (DLBCL and MCL) B-cell Lymphoma. - GALE
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
- GELARC
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
- •Phase IB only: Histologically documented CD20-positive follicular lymphoma (WHO grade 1, 2, or 3a) patients
- •Phase II only: patients with either histologically documented CD20-positive Diffuse large-cell lymphoma or Mantle cell lymphoma (cohort 1) or follicular lymphoma, WHO grade 1, 2 or 3a (cohort 2)
- •Phase IB and II:
- •- Relapsed/refractory NHL after =1 prior R-containing regimen with no curative option
- •- Aged 18 years or more
- •- ECOG performance status 0, 1 or 2
- •- At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter > 1.5 cm and a short axis =
- •- Signed inform consent
- •- Life expectancy of = 3 months
- •- All subjects must be able to understand and fulfill the lenalidomide Pregnancy Prevention Plan requirements
- •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 148
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Previous treatment with obinutuzumab or lenalidomide
- •- Known CD20 negative status at relapse/progression. Biopsy at relapse/progression is recommended but not mandatory
- •- Central nervous system or meningeal involvement by lymphoma
- •- Contraindication to any drug contained in the study treatment regimen
- •- Known HIV or HTLV-1 infection, positive serology to HB surface antigen [HBsAg] or total HB core antibody [anti-HB-c]) and Hepatitis C (Hepatitis C virus [HCV] antibody)
- •- Any serious active disease or co-morbid medical condition (such as New York Heart Association Class III or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator’s decision)
- •- Any of the following laboratory abnormalities.
- •o Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
- •o Platelet count < 100,000/mm3 (100 x 109/L) unless due to lymphoma for phase II part.
- •o Serum SGOT/AST or SGPT/ALT 3.0 x upper limit of normal (ULN) unless disease involvement.
- •o Serum total bilirubin > 2.0 mg/dL (34 µmol/L), except if disease related or in case of Gilbert syndrome.
- •- Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) of < 50 mL /min. For phase II part of the study, patients with calculated
- •creatinine clearance between 30 and 50ml/min can be included and lenalidomide dose will be adjusted as follows (10mg once daily).
- •- Prior history of malignancies other than lymphoma unless the subject has been free of the disease for = 5 years
- •- Any serious medical condition, laboratory abnormality (other than mentioned above), or psychiatric illness that would prevent the subject from signing the informed consent form.
- •- Pregnant or lactating females.
- •- Prior = Grade 3 allergic reaction/hypersensitivity to thalidomide.
- •- Prior = Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
- •- Subjects with = Grade 2 neuropathy.
- •- Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy
- •- Patients taking corticosteroids during 4 weeks before inclusion, unless administered at a dose equivalent to = 10 mg/day prednisone (over these 4 weeks).
研究者
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