(CHANT)A Prospective, Multicenter, Non-interventionistic Real-world Study of Duvelisib Capsules in the Treatment of Non-Hodgkin's Lymphoma (NHL).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Adverse events (AE)
研究概览
简要总结
This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib capsules in patients with non-Hodgkin's lymphoma.
详细描述
This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib administered to subjects who have been diagnosed with non-Hodgkin's lymphoma that is relapsed or refractory, including but not limited to the following subtypes : a) Follicular lymphoma(FL); b) Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome(CLL/SLL or RS); c) Marginal zone lymphoma(MZL); d) Peripheral T-cell lymphoma(PTCL); e) Diffuse large B-cell lymphoma(DLBCL).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •To participate in the study voluntarily and sign the informed consent (ICF), with good compliance and cooperative visits;
- •Patients must be ≥ 18 years of age (Based on the date of signing the informed Consent (ICF));
- •Pathologically or Histologically confirmed NHL including but not limited to the following subtypes:
- •Follicular lymphoma (FL);
- •Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome (CLL/SLL or RS);
- •Marginal zone lymphoma (MZL);
- •Peripheral T-cell lymphoma (PTCL);
- •Diffuse large B-cell lymphoma (DLBCL).
- •Patients who have received at least one systemic chemotherapy and have relapsed at the end of the treatment or progressed during treatment;
- •Must have adequate organ function defined by the following laboratory parameters:
- •Bone marrow function: Absolute neutrophil count (ANC) ≥ 0.5 × 10^9/L, Platelet count (PLT) ≥ 25 × 10^9/L, blood transfusion can be used before medication;
- •Liver and kidney function: Aspartate transaminase (AST) and alanine aminotransferase (ALT)≤5.0 × ULN;
- •Estimated creatinine clearance value ≥30 milliliters/minute (as determined by the Cockcroft-Gault method).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •Patients with infections should be treated first and then considered for enrollment when the infection is under control.
排除标准
- •Female subjects who are pregnant or breastfeeding;
- •Estimated lifetime is less than 3 months;
- •In the investigator's judgment, patients who require but are unable to receive prophylactic treatment for Pneumocystis or herpes simplex virus (HSV) prior to trial drug treatment;
- •History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function;
- •Prior history of drug-induced colitis or drug-induced interstitial pneumonia;
- •Known hypersensitivity to Duvelisib or its excipients;
- •Administration of medications or foods that are strong inhibitors or inducers of CYP3A beginning 2 weeks prior to the first dose of Duvelisib;
- •According to the judgement of the researcher, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study.
研究组 & 干预措施
All enrolled patients.
All patient who signed the consent form for participation to the study.
干预措施: Duvelisib (Drug)
结局指标
主要结局
Adverse events (AE)
时间窗: From the first day of medication to 30 days after the last dose]
The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.
次要结局
- Overall survival (OS)(4 year)
- Overall Response Rate (ORR)(up to 6 cycles of therapy (each cycle is 28 days)])
- Quality of life (QOL)(4 year)
- Duration of remission (DOR)(4 year)
- Progression-Free-Survival (PFS)(4 year)
研究者
Zhao Weili
Principal Investigator
Ruijin Hospital