NCT02678299进行中（未招募）1 期
Phase 1/2 Study of the Combination of Pixantrone, Etoposide, Bendamustine and, in CD20 Positive Tumors, Rituximab in Patients With Relapsed Aggressive Non-Hodgkin Lymphomas of B- or T-cell Phenotype - the P[R]EBEN Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 18
- 主要终点
- MTD of pixantrone, bendamustine and etoposide in 'fit' relapsed aNHL pts (phase 1)
研究概览
简要总结
This is a phase 1/2 open label study to assess the safety and efficacy of pixantrone in combination with bendamustine, etoposide and , for CD20 positive B-cell lymphomas, rituximab (P[R]EBEN), in patients with relapsed aNHL of B- or T-cell phenotype.
详细描述
This is a phase 1/2 open label study to assess the safety and efficacy of pixantrone in combination with bendamustine, etoposide and , for CD20 positive B-cell lymphomas, rituximab (P[R]EBEN), in patients with relapsed aNHL of B- or T-cell phenotype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a histologically confirmed relapse of an aggressive lymphoma of T- or B-cell phenotype (including follicular lymphoma grade 3b). For excluded histological entities see 'Exclusion criteria'
- •Phase 1 + Phase 2 'fit' patients:
- •Age 18-70 years at the time of inclusion
- •ECOG PS 0-1 at protocol entry
- •Deemed 'fit' by the treating physician
- •Phase 2 'frail' patients:
- •Age 71-85 years at the time of inclusion and/or
- •ECOG PS 2-3 at protocol entry and/or
- •Deemed 'frail' by the treating physician
- •At least six months response duration since last given course of treatment
- •Estimated life expectancy of 3 months or longer
- •Measurable disease
- •Hemoglobin ≥ 8 g/dL (≥5 mmol/l)
- •Platelets ≥ 100 x 109/L; ≥ 75 x 109/L permitted if bone marrow involvement
- •Absolute neutrophil count ≥ 1.5 x 109/L; ≥ 1.0 x 109/L permitted if documented bone marrow involvement
- •Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); patients with proven Gilbert's syndrome (≤ 5 x ULN) may be enrolled.
- •Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma
- •Serum creatinine ≤ 2 x ULNb
- •Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 12 months after the last administration of study drugs
- •Male patients must use contraception for the duration of the study and 6 months after the last administration of study drugs if his partner is of childbearing potential
- •Written informed consent
排除标准
- •Patients with primary refractory disease (e.g. progressing under platinum-containing or similar salvage therapy) defined as < 6 months response duration from last given course of treatment.
- •High-dose therapy with autologous stem cell rescue within the last 6 months prior to study entry.
- •Following T-cell lymphoma entities:
- •T-cell lymphoblastic lymphoma
- •Hepatosplenic T-cell lymphoma
- •Extranodal NK/T, nasal type
- •Subcutaneous panniculitis-like
- •Primary cutaneous T-cell lymphoma
- •Primary leukemic T-cell lymphoma
- •Following B-cell lymphoma entities:
- •Transformed indolent B-cell lymphomas
- •Post-transplant B-cell lymphoproliferative disease
- •HIV-associated B-cell lymphoma
- •Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related
- •Left ventricular ejection fraction (LVEF) < 45%
- •Suspected or documented central nervous system involvement by NHL
- •Patients known to be antigen positive for HIV and/or hepatitis B and/or hepatitis C
- •Patients with active, uncontrolled infections
- •Vaccination with live, attenuated vaccines within 4 weeks of inclusion
- •Pregnant and/or breastfeeding women
- •History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
- •Known hypersensitivity to one or more of the study drugs
- •Unwillingness or inability to comply with the protocol
研究组 & 干预措施
Treatment
Experimental
干预措施: PREBEN (Drug)
结局指标
主要结局
MTD of pixantrone, bendamustine and etoposide in 'fit' relapsed aNHL pts (phase 1)
时间窗: 1.5 yrs
Objective ORR in both 'fit' and 'frail' relapsed aNHL pts (phase 2)
时间窗: 4 yrs
次要结局
未报告次要终点
研究者
研究点 (18)
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