NL-OMON52350已完成不适用
A Phase 1b, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Combination with JNJ-67856633 in Participants with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia - Phase 1b study with JNJ64264681 and JNJ67856633 in patients with NHL en C
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. >=18 years of age
- •2. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- •3. Cardiac parameters within the following range: corrected QT interval (QTcF)
- •<= 480 milliseconds
- •4. Participants with B cell non-Hodgkin lymphoma (NHL) must have tumor tissue
- •available at baseline as described in the protocol. This is not required for
- •participants with chronic lymphocytic leukemia (CLL)
- •5. Women of childbearing potential must agree to use a barrier method of
- •contraception; use a highly effective preferably user-independent method of
- •contraception; not to donate eggs (ova, oocytes) or freeze them for future use
- •for the purposes of assisted reproduction during the study; not to plan to
- •become pregnant; and not to breastfeed
排除标准
- •1. Part A and select cohorts in Part B: Prior treatment with JNJ-64264681 or
- •JNJ-67856633. Previously discontinued treatment with a BTK or MALT inhibitor
- •other than JNJ-64264681 or JNJ-67856633 due to participant or doctor choice
- •without evidence of progression or intolerable class-related toxicity will be
- •2. Known (active) CNS involvement for dose escalation and specific expansion
- •cohorts as determined by the SET.
- •3. Received prior solid organ transplantation.
- •4. Participant has known allergies, hypersensitivity, or intolerance to
- •JNJ-64264681 or JNJ-6785566 or excipients (refer to the respective IBs).
- •5. Toxicities from previous anti-cancer therapies that have not resolved to
- •baseline levels, or to Grade <2 (except for alopecia [>=Grade 2], vitiligo
- •[Grade 2] and peripheral neuropathy [Grade 1]).
研究者
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