JPRN-jRCT2021220031招募中1 期
A Phase I/II Open-Label Study of MT-2111 in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Kazuoki Kondou0 个研究点目标入组 49 人开始时间: 2022年11月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 49
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •;Patients who were diagnosed pathologically with DLBCL, NOS, DLBCL transformed from indolent B-cell lymphoma, or high-grade B-cell lymphoma with DLBCL morphology and with MYC and BCL2 and/or BCL6 rearrangements, based on the 2017 WHO classification.
- •;Patients with relapsed or refractory disease despite 2 or more prior systemic therapies.
- •;Japanese patients aged >= 18 years at the time of informed consent. For Japanese subjects, it should be confirmed that the parents who are related by blood to the subject must be Japanese.
- •;Patients who have a lesion that can be assessed for staging and evaluated for response according to the Lugano criteria (2014). A lesion that has received radiotherapy as the most recent treatment will be considered as a measurable lesion only when progression has been documented following completion of the radiotherapy.
- •;Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening.
排除标准
- •;Patients with a pathological diagnosis of Burkitt's lymphoma.
- •;Patients with bulky disease with the longest dimension of >= 10 cm.
- •;Patients with a history or complication of post-transplant lymphoproliferative disorders.
- •;Patients with lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease.
- •;Patients complicated with other active malignancies or patients with a history of other malignancies within 3 years before informed consent. However, the following are exceptional:
- •Non-melanoma skin cancer
- •Non-metastatic prostate cancer
- •Cervical carcinoma in situ
- •Ductal carcinoma in situ or lobular carcinoma in situ
- •;Patients with clinically significant third space fluid accumulation (e.g., ascites requiring drainage or pleural effusion requiring drainage or associated with shortness of breath).
- •;Patients who underwent autologous hematopoietic stem cell transplantation (AHSCT) within 30 days prior to the start of study drug administration (Cycle 1 Day 1).
- •;For the Phase I part, patients with prior allogeneic stem cell transplantation (Allo-HSCT) before the start of study drug administration (Cycle 1 Day 1). For the Phase II part, patients undergoing Allo-HSCT within 60 days prior to the start of study drug administration (Cycle 1 Day 1).
- •;Patients who had a positive HIV antigen-antibody test or HIV antibody test.
- •;Patients positive for HBs antigen, HBc antibody, or HBs antibody. However, patients who meet any of the following are eligible:
- •The patient's HBs antibody positivity is clearly due to vaccination.
- •Patients who are positive for HBs antibody and/or HBc antibody with HBV-DNA not detected and agree to undergo HBV-DNA tests once a month from the start of study drug administration to at least 12 months after the completion of study drug administration.
- •;Patients positive for HCV antibody. However, patients with negative HCV-RNA are eligible.
- •;Patients who received anticancer therapy during the following periods prior to the start of study drug administration (Cycle 1 Day 1).
- •Cytotoxic chemotherapy: within 14 days.
- •Antibody therapy: within 5 half-lives or 14 days, whichever is longer (including monoclonal antibody preparations, radioimmunoconjugates, or antibody-drug conjugates). Within 14 days for rituximab.
- •Radiotherapy: within 14 days
- •CAR-T therapy: within 100 days
- •Other anticancer therapy: within 14 days
- •;Patients who received treatment with any other investigational product within 14 days prior to the start of study drug administration (Cycle 1 Day 1). However, for the Phase I part, patients who received any other investigational product within 14 days or 5 half-lives, whichever is longer, before the start of study drug administration (Cycle 1 Day 1).
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