2023-507286-25-00招募中2 期
VERLEN - Phase II, Open-Label Study evaluating efficacy of Lenalidomide and Tafasitamab combination associated to Rituximab in frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or older
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- LYSARC
- 入组人数
- 45
- 试验地点
- 20
- 主要终点
- ORR encompasses patients that reach Complete Metabolic Response or Partial Metabolic Response based on investigator disease assessment according to Lugano Response Criteria.
研究概览
简要总结
Evaluate the efficacy of tafasitamab (anti-CD19 antibody) and lenalidomide associated with rituximab (R-Tafa-Len) in elderly patients as assessed by the Overall Response Rate (ORR) after 3 cycles of treatment or at permanent treatment discontinuation, whichever occurs first.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Treatment period
- 盲法
- None
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient must understand and voluntarily sign an Informed Consent Form prior to any study-specific assessments/procedures being conducted
- •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)
- •Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2017) including all clinical subtypes (primary mediastinal, intravascular, etc…), with all 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, NOS • Follicular lymphoma grade 3B
- •Positron-Emission Tomography (PET)-positive disease
- •Previously untreated high-grade B-cell lymphoma
- •Aged ≥ 80 years old at the time of signing the informed consent form (ICF)
- •Ann Arbor stage I, II, III or IV
- •ECOG performance status ≤ 2
- •With a minimum life expectancy of 3 months
- •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
排除标准
- •Any other histological type of lymphoma, Burkitt included
- •Known HIV, active HCV infection or positive 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
- •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 <1G/L or platelets <100G/L, even if there is bone marrow infiltration by lymphoma. A Bone Marrow Aspiration will be mandatory prior inclusion for patients with neutrophils <1.5 G/L or Hemoglobin <9g/dL in order to exclude patients with concomitant myelodysplasia.
- •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
结局指标
主要结局
ORR encompasses patients that reach Complete Metabolic Response or Partial Metabolic Response based on investigator disease assessment according to Lugano Response Criteria.
ORR encompasses patients that reach Complete Metabolic Response or Partial Metabolic Response based on investigator disease assessment according to Lugano Response Criteria.
次要结局
- Central review of PET-CT according to Lugano Response Criteria
- Complete Metabolic response (CMR) rates based on investigator disease assessment and central assessment
- Overall Survival (OS)
- Quality of Life (QoL)
- Progression Free Survival (PFS)
- Assess safety of lenalidomide and tafasitamab in the context of patients treated by rituximab
研究者
Benoit TESSOULIN
Scientific
LYSARC
研究点 (20)
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