2024-514775-17-00招募中2 期
A prospective, multicenter phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with Tafasitamab (MOR208) for patients with relapsed/refractory transformed or Aggressive Lymphoma (GOAL II)
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR11 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年8月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 11
- 主要终点
- ORR of the regimen within the first 8 treatment cycles
研究概览
简要总结
Determination of the ORR in the experimental arm and comparison to historic results (Analysis will be based on Lugano -Criteria ).
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Period 1
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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)
- •Signed informed consent
- •Adequate contraception (if needed)
- •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
排除标准
- •CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
- •Hepatitis C
- •active Hepatitis 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
- •no adequate pretreatment (R-CHOP-like, or BR for initial indolent lymphoma)
- •systemic treatment within last 6 weeks, steroids for bridging are allowed
- •prior allogeneic transplantation 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
结局指标
主要结局
ORR of the regimen within the first 8 treatment cycles
ORR of the regimen within the first 8 treatment cycles
次要结局
- ORR (Cheson 2007-criteria)
- Progression free survival (Lugano)
- Overall survival
- CR-Rate (Lugano)
- Best response (Lugano)
- Quality of Life measured with EORTC QLQ C30 and NHL-HG29 (global QoL, physical functioning, fatigue)
- ORR in separate GCB vs. non GCB-analysis is planned
- Safety Endpoints: Safety and tolerability as measured by rate of AE, SAE compared between Arm A and B
研究者
Sponsor contact point clinical trials
Scientific
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
研究点 (11)
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