EUCTR2012-002602-52-AT进行中（未招募）1 期
Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY 80-6946 in patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas - Phase II PI3K inhibitor in relapsed, indolent or aggressive NH
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 330
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
- •Indolent NHL:
- •- Histologically confirmed diagnosis of follicular lymphoma (FL) grades 1, 2 or 3a, marginal zone lymphoma (including nodal or splenic marginal zone B-cell
- •lymphoma and mucosa-associated lymphoid tissue [MALT]
- •lymphoma), lymphoplasmacytic lymphoma/Waldenström
- •macroglobulinemia, chronic lymphocytic leukemia (CLL).
- •- Relapsed after = 2 prior chemotherapy- or immunotherapy-based regimens for indolent NHL, or refractory to 2 prior chemotherapy and/ or immunotherapy-based regimens.
- •Aggressive NHL:
- •- Histologically confirmed diagnosis of grade 3b follicular lymphoma (FL), transformed indolent lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal large B-cell lymphoma, mantle cell lymphoma (MCL), peripheral T-cell lymphoma unspecified, or anaplastic large cell lymphoma primary systemic type, or angioimmunoblastic T cell lymphoma.
- •- Relapsed after = 2 prior chemotherapy regimens, including the following: First-line treatment with standard anthracycline-containing regimen (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone or equivalent). At least 1 additional combination
- •chemotherapy regimen. Patients relapsed after or refractory to first prior chemotherapy- and/or immunotherapy-based regimen for aggressive NHL and not eligible for high-dose regimen followed by transplant. High-dose chemotherapy, or chemoradiotherapy with autologous stem cell transplantation is considered 1 regimen. Patients with CD20
- •expressing neoplastic cells must have received prior rituximab, if available.
- •- Patients with transformed indolent lymphoma must have received at least 2 prior chemotherapy- and/or immunotherapy-based regimens
- •- Availability of fresh tumor tissue
- •Indolent B-cell NHL lymphoma (study part B):
- •- Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:
- •o Follicular lymphoma (FL) grade 1-2-3a
- •o Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 109/L at the time of diagnosis and at study entry
- •o Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
- •o Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)
- •- Relapsed or refractory after = 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have received Rituximab and alkylating agents.
- •For all patients:
- •- Male or female patients > 18 years of age
- •- ECOG performance status = 2 (ECOG: Eastern Cooperative
- •Oncology Group)
- •- Life expectancy of at least 3 months
- •- Adequate bone marrow, liver and renal function as assessed within 7 days before starting study treatment
- •- Left ventricular ejection fraction (LVEF) = lower limit of normal (LLN) for the Institution
- •- Availability of archival and/or fresh tumor tissue
- •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 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •For Part A:
- •-Uncontrolled hypertension (blood pressure = 150/90 mmHg despite optimal medical management)
- •-Current diagnosis of Type 1 or 2 diabetes mellitus, fasting blood glucose > 125 mg/dL (> 6.9 mmol/L) or HbA1c = 7.0 % (HbA1c: glycated hemoglobin)
- •- Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event = CTCAE Grade 3 within 4 weeks of start of study medication (CTCAE: Common Terminology Criteria for Adverse Events).
- •- History or concurrent condition of interstitial lung disease or severely impaired pulmonary function (as judged by the investigator).
- •- Unresolved toxicity higher than CTCAE grade 1 (NCI-CTC version 4.0) attributed to any prior therapy/procedure excluding alopecia. (NCI: National Cancer Institute)
- •- Prior treatment with PI3K inhibitors
- •- Systemic corticosteroid therapy (ongoing)
- •- Hepatitis B or C. All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA.
- •- Uncontrolled hypertension (blood pressure = 150/90 mmHg despite optimal medical management)
- •- Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event = CTCAE Grade 3 within 4 weeks of start of study medication (CTCAE: Common Terminology Criteria for Adverse Events).
- •- History or concurrent condition of interstitial lung disease or severely impaired pulmonary function (as judged by the investigator)
- •- Unresolved toxicity higher than CTCAE grade 1 (NCI-CTC version 4.0) attributed to any prior therapy/procedure excluding alopecia. (NCI: National Cancer Institute)
- •- Prior treatment with PI3K inhibitors
- •- Systemic corticosteroid therapy (ongoing)
- •- Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at Screening
- •- Known history of human immunodeficiency virus (HIV) infection.
- •- Hepatitis B or C. All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for
- •HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA.
- •- Known lymphomatous involvement of the central nervous system
研究者
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