DRKS00023793进行中（未招募）2 期
A prospective, multicenter phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with Tafasitamab (MOR208) for patients with relapsed/refractory transformed aggressive Lymphoma - GOAL II
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Histologically proven diagnosis of
- •a) diffuse large cell B-cell lymphoma, and other aggressive B-cell lymphomas according to the WHO 2016 revision (specified in detail in the protocol)
- •b) follicular lymphoma grade 3B and
- •c) transformed indolent B-cell lymphoma (not more than 20 % of the patient population) according to the WHO classification (central pathology review);
- •- Relapsed disease or refractory disease, at least one but no more than two prior treatment lines;
- •- age = 18 years;
- •- No curative option available (age = 65yr and/or HCT-CI Score > 2) or s.p. HDT;
- •- At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration;
- •- Adequate bone marrow reserve:
- •a) Platelets of at least 100 000/µl
- •b) absolute neutrophil count of at least 1000/µl;
- •- Adequate hepatic and renal function:
- •a) Alanine aminotransferase (ALT) <2.5 x upper limit of normal (ULN)
- •b) Aspartate aminotransferase (AST) <2.5 x upper limit of normal (ULN)
- •c) Total bilirubin <1.5 x upper limit of normal (ULN) unless related to lymphoma;
- •- Measured or calculated eGFR >50 ml/min (institutional standard);
- •- Eastern Cooperative Oncology Group (ECOG) performance Status =2, unless tumor associated and expected to improve on treatment;
- •- Signed informed consent;
- •- Adequate contraception (if needed)
排除标准
- •CNS involvement (brain MRI is required only in cases of clinically suspicious involvement);
- •- no adequate pretreatment (R-CHOP-like);
- •- systemic treatment within last 6 weeks, steroids for bridging are allowed;
- •- prior allogeneic transplantation and prior anti CD19 CAR T-cell therapy or prior tafasitamab therapy;
- •- pregnant or breast-feeding women;
- •- severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinemia);
- •- Prolongation of QTc interval > 450 ms, demonstrated in electrocardiogramm (two separate or one in triplicate) or family history for Long QT-syndrome;
- •- active uncontrolled infections;
- •- HIV-positivity; Hepatitis C;
- •- active Hep B, patients with HBs-Ag positivity and no measurable HBV-DNA are eligible;
- •- Medical or psychological condition that would not permit completion of the trial or signing of informed consent;
- •- Diagnosed or treated for a malignancy other than NHL except:
- •a) adequately treated non-melanoma skin cancer
- •b) curatively treated in-situ cancer of the cervix
- •c) ductal carcinoma in situ (DCIS) of the breast
- •d) other solid tumors curatively treated with no evidence of disease for >2 years
- •e) prostate cancer with a life expectancy of more than 2 years;
- •- Concurrent treatment with another investigational agent or within the last 6 weeks prior to treatment initiation. Concurrent participation in non-treatment studies is not excluded.;
- •- Known intolerance to any of the study drugs or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
研究者
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