EUCTR2014-003893-17-IT进行中（未招募）1 期
Combination of ibrutinib and bortezomib followed by ibrutinib maintenance to treat patients with relapsed and refractory mantle cell lymphoma; a multicenter Phase I/II trial - SAKK 36/13
SAKK0 个研究点目标入组 55 人开始时间: 2020年12月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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
- •-Mantle cell lymphoma with either overexpression of cyclin D1 protein or evidence of t
- •-Refractory or relapsed LCM after pretreatment with nonbortezomib-containing chemotherapy
- •-At least one measurable lesion =11 mm (greatest transverse diameter) measured with CT scan or MRI
- •-Adequate hematological values, hepatic and renal function
- •-Effective method of birth control in women of childbearing potential and men who are sexually active
- •-Negative pregnancy test in women of childbearing potential; breastfeeding women are ineligible for this trial
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •-Prior therapy with ibrutinib or bortezomib
- •-Actual or prior presence of the disease in the CNS
- •-Exclusion of the following prior treatments prior to trial registration
- •o major surgery within 4 weeks
- •o concurrent treatment with other experimental drugs or treatment in a clinical trial within
- •o treatment with chemotherapy and radiotherapy within 3 weeks
- •o vaccinated with live, attenuated vaccines within 4 weeks
- •-History of stroke or intracranial hemorrhage within 6 months prior to trial registration
- •-Requires anticoagulation with warfarin or equivalent vitamin K antagonists
- •-Requires treatment with strong or moderate CYP3A inhibitors
- •-Prior allogeneic bone marrow or solid organ transplantation
研究者
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