JPRN-jRCT2080223990已完成2 期
A phase II Study of Polatuzumab Vedotin (RO5541077) in Combination with Rituximab plus Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
The study met the primary efficacy endpoint of CRR with Polatuzumab Vedotin in combination with Rituximab plus Bendamustine in Japanese patients with transplant-ineligible R/R DLBCL. Efficacy and safety data were comparable with the results obtained in the previous global randomized phase 2 study (GO29365), confirming the role of this regimen in this population.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Histologically confirmed CD20 positive DLBCL
- •- Patients with relapsed or refractory diffuse large B-cell lymphoma who received at least one prior therapy
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2.
- •- Life expectancy of at least 24 weeks from enrollment
- •- Bi-dimensionally measurable lesion (defined as >= 1.5 cm in its longest dimension)
- •- Availability of tumor tissue or 13 unstained slides
- •- Patients with sufficient hematological function
排除标准
- •- Contraindication to bendamustine or rituximab
- •- History of transformation of indolent lymphoma to DLBCL
- •- Primary or secondary CNS (central nervous system) lymphoma
- •- Patients with a medical history of double cancer with disease-free interval of less than 3 years or complicated with double cancer.
- •- Prior allogeneic stem cell transplant
- •- Eligibility for autologous hematopoietic stem cell transplant
- •- Grade >= 2 peripheral neuropathy
- •- Active infections
- •- Patients with suspected or latent tuberculosis
- •- Positive HBsAg, HBcAb, HBsAb (Patients who are positive test results for HBsAb and/or HBcAb only and undetectable HBV-DNA may be eligible)
- •- Positive anti-HCV (Patients who are negative for HCV-RNA may be eligible)
- •- Known HIV antibody positive status or infection with HTLV-1
研究者
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