NCT04974216进行中（未招募）2 期
Phase II, Open-Label Study Evaluating Efficacy of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older
The Lymphoma Academic Research Organisation20 个研究点 分布在 2 个国家目标入组 71 人开始时间: 2021年12月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 71
- 试验地点
- 20
- 主要终点
- Overall Response Rate (ORR) by local assessment
研究概览
简要总结
This study evaluate the efficacy of Tafasitamab and Lenalinomide associated to Rituximab in elderly patients with frontline Diffuse Large B-Cell Lymphoma as assessed by the Overall Response Rate (ORR) after 3 cycles of treatment according to Lugano Response Criteria.
详细描述
This study is an open-label, multi-centric, phase II study designed to evaluate the efficacy of Tafasitamab and Lenalinomide associated to Rituximab in elderly patients with frontline Diffuse Large B-Cell Lymphoma as assessed by the Overall Response Rate (ORR) after 3 cycles of treatment according to Lugano Response Criteria.
After a screening phase, eligible patients will be enrolled and start the prephase treatment with vincristine and prednisone before day 1 of cycle 1 of the experimental drugs.
Patients with Progressive Disease or Stable Disease after 3 cycles should start a conventional chemotherapy (R-miniCHOP) at Investigator's discretion and will remain in the study.
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
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2.Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2017) including all clinical subtypes (primary mediastinal, intravascular, etc…), with all International Prognostic Index (IPI). May also be enrolled the following malignancies:
- •De Novo transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell infiltration in bone marrow or lymph node.
- •High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
- •High-grade B-cell lymphoma, Not Otherwise Specified (NOS)
- •Follicular lymphoma grade 3B 3.Positron-Emission Tomography (PET)-positive disease 4.Previously untreated high-grade B-cell lymphoma 5.Aged ≥ 80 years old at the time of signing the informed consent form (ICF) 6.Ann Arbor stage I, II, III or IV 7.Eastern Cooperative Oncology Group (ECO)G performance status ≤ 2 8.With a minimum life expectancy of 3 months 9.Male patients must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 4 months following study drug discontinuation, even if they have undergone a successful vasectomy
- •Patients should be able to receive R-miniCHOP regimen (left ventricular ejection fraction > 50% and good general condition, according to investigator's judgment)
- •Patients should be able to receive adequate prophylaxis and/or therapy for thromboembolic events (aspirin or low molecular weight heparin)
- •Patient covered by any social security system (France)
排除标准
- •Any other histological type of lymphoma, Burkitt included
- •Any history of treated or non-treated Small-B cell lymphoma prior Aggressive B Cell lymphoma diagnosis
- •Central nervous system or meningeal involvement by lymphoma
- •Any serious active disease (according to the investigator's decision)
- •Poor renal function (calculated Cockcroft-Gault creatinine clearance < 30 ml/min)
- •Poor hepatic function (total bilirubin level >30 μmol/l, transaminases >2.5 upper normal limits) unless these abnormalities are related to lymphoma
- •Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration by lymphoma cells (Bone Marrow Aspiration will be mandatory in case of severe cytopenias prior inclusion)
- •Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score ≤7, and a prostate specific antigen (PSA) ≤10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (i.e., prostatectomy or radiotherapy) 2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy
- •Treatment with any investigational drug within 30 days prior to prephase treatment and during the study
- •Known HIV, active Hepatitis C Virus (HCV) infection or positive Hepatitis B Virus (HBV) test within 4 weeks before enrollment (except after hepatitis B vaccination or for patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative)
- •Prior treatment with anti-CD20/anti-CD19 monoclonal antibody or alemtuzumab within 3 months prior to prephase treatment
- •Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide
- •Contra-indication to highly dosed glucocorticoid (60 mg/m2/d)
- •Neuropathy ≥ Grade 2 or painful
- •Patient deprived of his/her liberty by a judicial or administrative decision
- •Adult patient under legal protection
研究组 & 干预措施
R-Lena-Tafa
Experimental
12 cycles of 28 days. From C1 to C6 : rituximab + tafasitamab + lenalidomide and from C7 to C12: tafasitamab and lenalidomide
Patients with Progressive Disease or Stable Disease after 3 cycles should start a conventional chemotherapy (rituximab + cyclophosphamide + adriamycine + vincristine + prednisone R-miniCHOP) at Investigator's discretion according to local practices
干预措施: Lenalidomide (Drug)
R-Lena-Tafa
Experimental
12 cycles of 28 days. From C1 to C6 : rituximab + tafasitamab + lenalidomide and from C7 to C12: tafasitamab and lenalidomide
Patients with Progressive Disease or Stable Disease after 3 cycles should start a conventional chemotherapy (rituximab + cyclophosphamide + adriamycine + vincristine + prednisone R-miniCHOP) at Investigator's discretion according to local practices
干预措施: Tafasitamab (Drug)
R-Lena-Tafa
Experimental
12 cycles of 28 days. From C1 to C6 : rituximab + tafasitamab + lenalidomide and from C7 to C12: tafasitamab and lenalidomide
Patients with Progressive Disease or Stable Disease after 3 cycles should start a conventional chemotherapy (rituximab + cyclophosphamide + adriamycine + vincristine + prednisone R-miniCHOP) at Investigator's discretion according to local practices
干预措施: Rituximab (Drug)
结局指标
主要结局
Overall Response Rate (ORR) by local assessment
时间窗: 3 months (3 cycles of 28 days)
LOCAL ASSESSMENT : Complete Metabolic Response + Partial Metabolic Response based according to Lugano Response Criteria
次要结局
- Progression free survival (PFS)(2 years)
- Number of Serious Adverse Events (SAE) of patients treated with lenalidomide and tafasitamab(13 months)
- Number of SAE of patients who switched to RminiCHOP(7 months)
- Overall Response Rate (ORR) by local assessment(12 months (12 cycles of 28 days = end of treatment))
- Overall survival (OS)(2 years)
- Complete Metabolic Response (CMR) by central assessment(12 months (12 cycles of 28 days = end of treatment))
- Complete Metabolic Response (CMR) by local assessment(12 months (12 cycles of 28 days = end of treatment))
- Progression free survival (PFS) of patients who switched to RminiCHOP(3 years)
- Overall survival (OS) of patients who switched to RminiCHOP(3 years)
- Overall Response Rate (ORR) by central assessment(12 months (12 cycles of 28 days = end of treatment))
- Overall Response Rate (ORR) by central assessment(3 months (3 cycles of 28 days))
- Complete Metabolic Response (CMR) by local assessment(3 months (3 cycles of 28 days))
- Complete Metabolic Response (CMR) by central assessment(3 months (3 cycles of 28 days))
- Complete Metabolic Response (CMR) by local assessment(6 months (6 cycles of 28 days))
- Complete Metabolic Response (CMR) by central assessment(6 months (6 cycles of 28 days))
- Overall Response Rate (ORR) by local assessment(6 months (6 cycles of 28 days))
- Overall Response Rate (ORR) by central assessment(6 months (6 cycles of 28 days))
研究者
研究点 (20)
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