EUCTR2013-003749-40-HU进行中（未招募）1 期
A Phase Ib/II, open label study evaluating the safety and pharmacokinetics of GDC-0199 (ABT-199) in combination with Rituximab (R) or Obinutuzumab (G) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with B Cell non-hodgkin's lymphoma (NHL) and DLBC
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 264
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
- •General Inclusion Criteria:
- •- Patients, age >= 18 years
- •- At least one bi-dimensionally measurable lymphoma lesion defined as > 1.5 cm in its longest dimension which is also FDG avid by screening PET scan
- •- Ability and willingness to comply with the study protocol procedures
- •- Confirmed availability of archival or freshly biopsied tumor tissue prior to study enrollment
- •- ECOG performance status of 0, 1, or 2
- •- Adequate hematologic function
- •- For female patients of childbearing potential and male patients with female partners of childbearing potential, agreement to use highly effective forms of contraception
- •Dose Finding Portion of the Study:
- •- Patients must have histologically confirmed B-cell non-Hodgin's Lymphoma (NHL)
- •- Patients must have never received previous R-CHOP treatment
- •- Any relapsed/refractory patients that are enrolled during the dose escalation should have received only a single previous treatment regimen
- •Phase II Portion of the Study:
- •- Patients must have previously-untreated CD20-positive diffuse large, B-cell lymphoma
- •- International prognostic index (IPI) score must be 2-5
- •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 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
排除标准
- •General Exclusion Criteria:
- •- Contraindication to receive any of the individual components of CHOP, rituximab or obinutuzumab
- •- CNS lymphoma or primary mediastinal DLBCL
- •- Vaccination with live vaccines within 28 days prior to randomization
- •- History of other malignancy that could affect compliance with the protocol or interpretation of results
- •- Evidence of significant, concomitant disease or illness
- •- Use of CYP3A inhibitors or inducers within 7 days of the first dose of venetoclax
- •- Recent major surgery
- •- Women must not be pregnant or breastfeeding
- •Dose Finding Portion of the Study:
- •- Histologically confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma (SLL)
- •Phase II Portion of the Study:
- •- Patients with transformed lymphoma (patients with discordant bone marrow involvement [i.e., low grade histology in bone marrow] may be considered after discussion with the Medical Monitor)
- •- Prior therapy for non-hodgkin's lymphoma (NHL)
研究者
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