NCT06062641尚未招募2 期
Selinexor Combined With R-GDP Regimen for TP53-altered Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Single Arm, Single Center, Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
To evaluate the efficacy and safety of selinexor combined with R-GDP regimen in the treatment of patients with TP53-altered relapsed or refractory B-cell lymphoma.
详细描述
This study is a single-arm, open-label exploratory clinical trial. To evaluate the efficacy and safety of selinexor combined with R-GDP regimen in the treatment of patients with TP53-altered relapsed or refractory B-cell lymphoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed primary DLBCL or previously diagnosed indolent lymphoma (e.g., follicular lymphoma) transformation to DLBCL with TP53 deletion or mutation confirmed by FISH or next-generation sequencing.
- •Received at least 1 but no more than 3 previous lines of systemic therapy for DLBCL, and was relapsed or refractory to the last line of therapy Salvage chemoimmunotherapy and subsequent stem cell transplantation are considered the same first-line systemic therapy Maintenance therapy will not be counted separately as first-line systemic therapy Radiotherapy for curative treatment of localized DLBCL lesions does not count as first-line systemic therapy
- •Presence of measurable positron-emission tomography (PET) -positive lesions with at least one lymph node lesion long diameter (LDi) > 1.5 cm or an extra-nodal lesion LDi > 1 cm (according to the Lugano classification, 2014 version)
- •Bone marrow function was good at screening Absolute neutrophil count (ANC) ≥1×109/L Platelet count ≥50×109/L (no platelet transfusion < 14 days before cycle 1 day 1, C1D1) Hemoglobin ≥8.0 g/dL (no red blood cell transfusion < 14 days before C1D1)
- •Good liver and kidney function, namely:
- •AST or ALT ≤2.5× upper normal value limit (ULN), or ≤5×ULN in the presence of known lymphoma involving the liver Serum total bilirubin ≤2×ULN, or when Gilbert's syndrome or known lymphoma involves the liver≤5×ULN CrCl≥30 mL/min according to the Cockcroft-Gault formula
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Estimated life expectancy at screening was > 3 months
- •Agree to use a highly effective contraceptive during the study, which lasts for 12 months after the last dose of study treatment
排除标准
- •Patients who met any of the following exclusion criteria were not eligible for the study:
- •Prior treatment with selinexor or another XPO1 inhibitor
- •There are contraindications to any drug in the combination therapy
- •Receipt of any standard or investigational anti-DLBCL therapy <21 days before C1D1 (including non-palliative radiotherapy, chemotherapy, immunotherapy, radioimmunotherapy, or any other anticancer therapy) (Palliative radiotherapy for non-target lesions was allowed)
- •Undergone major surgery <14 days before C1D1
- •Hematopoietic stem cell transplantation /CAR-T therapy requirements are as follows:
- •Autologous hematopoietic stem cell transplantation (HSCT) <100 days or allogeneic HSCT <180 days prior to C1D1 Active graft-versus-host disease (GVHD) after allogeneic HSCT (or inability to discontinue GVHD therapy or preventive therapy) CAR-T cell infusion <90 days before cycle 1
- •Presence of grade ≥2 neuropathy (CTCAE, v.5.0)
- •Presence of any life-threatening disease, medical condition, or organ system dysfunction that is considered by the investigator to be likely affecting patient safety or adherence to study procedures
- •Uncontrolled (i.e., clinically unstable) infection within 7 days before the first dose of study treatment and required treatment with intravenous antibiotics, antiviral drugs or antifungal drugs; However, prophylactic use of these agents was allowed.
- •Patients with active HBV, HCV, or HIV infection. Participants who were HBsAg positive and/or HBcAb positive but HBV-DNA negative, and/or HCV antibody positive but HCV-RNA negative were allowed to participate (the upper limit of normal values for HBV-DNA and HCV-RNA were based on the values available at each participating center).
- •Inability to swallow tablets, presence of a malabsorption syndrome, or any other condition that may interfere with absorption of the study drug
- •Lactating or pregnant women
- •Unable or unwilling to sign the ICF
- •Patients who were considered by the investigator to be significantly below tolerable weight
- •Patients who received live attenuated vaccine within 28 days prior to the first dose of study treatment
研究组 & 干预措施
SR-GDP
Experimental
干预措施: SR-GDP (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: At the end of Cycle 6 (each cycle is 21 days)
Objective Response Rate (ORR) : The investigator-assessed best disease status of patients with TP53-altered R/R DLBCL was the rate of Complete Response (CR) or Partial Response (PR)
次要结局
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Up to 30 days after completion of study treatment)
- progression free survival(Baseline up to data cut-off (up to approximately 2 years))
- overall survival(Baseline up to data cut-off (up to approximately 2 years))
研究者
Zhao Weili
Vice president，Ruijin hospital
Ruijin Hospital
研究点 (1)
Loading locations...
相似试验
招募中
2 期
XPO-1 in Combination With RCHOP for DH/TH LymphomaDouble Hit LymphomaTriple Hit LymphomaNCT05974085Zhejiang Cancer Hospital10
招募中
4 期
Selinexor Combined With R-GemOx as Second-line Treatment in Patients With Diffuse Large B-cell LymphomaDiffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedNCT05786989Chongqing University Cancer Hospital32
已完成
1 期
Selinexor and Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid LeukemiaAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Recurrent Adult Acute Myeloid LeukemiaSecondary Acute Myeloid LeukemiaNCT02299518Alice Mims23
尚未招募
Unknown
Phase 1/2 study of Selinexor in combination with dexamethasone, ifosfamide, carboplatin, etoposide chemotherapy in patients with secondary central nervous system involving relapsed or refractory B-cell non-Hodgkin lymphoma: a single arm, open label, multicenter studyKCT0008884Samsung Medical Center35
招募中
2 期
Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell LymphomaDLBCL Germinal Center B-Cell TypeNCT05422066Li Zhiming50