A Phase Ib/II, open label study evaluating the safery 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

F. Hoffmann- La Roche Ltd.0 个研究点目标入组 264 人开始时间: 2014年6月23日最近更新: 2020年11月9日

适应症

试验速览

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•General Inclusion Criteria:
•- Patients, age >= 18 years
•- At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its longest dimension
•- 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 Escalation 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
•Expansion Portion of the Study:
•- Patients must have previously-untreated 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

•General Exclusion Criteria:
•- Contraindication to receive any of the individual components of CHOP, rituximab or obinutuzumab
•- CNS lymphoma
•- 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
•- Requires use of Warfarin
•- Recent major surgery
•- Women must not be pregnant or breastfeeding
•Dose Escalation Portion of the Study:
•- Prior anthracycline therapy
•- Chemotherapy or other investigational therapy within 5 half-lives of a biologic agent with a minimum of 28 days prior to the start of Cycle 1
•- histologically confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma (SLL)
•Expansion Portion of the Study:
•- Patients with transformed lymphoma
•- Prior therapy for non-hodgkin's lymphoma (NHL)
•- Current Grade > 1 peripheral neuropathy

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