RPCEC00000266尚未招募1 期
Phase I / II study of dose escalation and expansion to cohorts, with the therapeutic antibody 14F7h (Anti-NGlicolilGM3) in patients with chronic B-cell lymphoproliferative syndrome, refractory or relapsing
Center of Molecular Immunology (CIM)0 个研究点目标入组 142 人开始时间: 2018年3月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Open. Control group: Dose comparison. Assignment: Other. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- All
入选标准
- •1. Refractory or relapsing B-cell cell lymphoproliferative syndrome, ganglioside NGlicolilGM3 (NGGM3) positive.
- •2. Age =18 years, any gender and race.
- •3. ECOG = 3.
- •4. Life expectancy of 6 months.
- •5. No candidates for transplant of hematopoietic progenitors or immunochemotherapy schemes not previously used.
- •6. Four or more weeks from the previous specific therapy (QT, RT, biological therapies) (applicable to patients’ refractory to the previous treatment).
- •7. Patients with laboratory parameters as detailed below: Hemoglobin = 80 g / L, Absolute neutrophil count = 1.5 x 109 / L, Platelet count = 75 x 109 / L, Liver function (bilirubin, ASAT or ALAT = 2.5 times the normal reference range of each institution), Renal function preserved (creatinine clearance =45 mL / min according to the Cockcroft and Gault formula).
- •8. Voluntary signature of the informed consent model.
- •9. Subjects of childbearing age and sexually active should agree to use a method of contraception during treatment (criteria valid only for patients of childbearing age).
排除标准
- •1. Pregnant, puerperal or breastfeeding
- •2. Cytopenia of uncontrolled immune cause
- •3. Active infection or known positivity for HIV, hepatitis B or C virus
- •4. Heart failure grade III / IV according to NYHA criteria (New York Heart Association)
- •5. Chronic decompensated diseases such as: arterial hypertension, diabetes mellitus, ischemic cardiopathy or other symptomatic cardiovascular diseases, epilepsy, obstructive pulmonary disease.
- •6. Acute allergic states or known hypersensitivity to any component of the formulation under study.
- •7. Obvious mental disability or other limitation that prevents the patient from signing their consent or hinders the evaluation of the study.
- •8. Being receiving another research product.
- •9. Another clinically active neoplasm that needs specific treatment (except basal cell carcinomas or cutaneous carcinomas in situ).
研究者
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