NCT06347653招募中2 期
A Single Arm, Open Label, Multicenter Clinical Trial of Linperlisib Combined With CHOP Regimen Followed by Autologous Hematopoietic Stem Cell Transplantation and Linperlisib Monotherapy Maintenance for Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL) Patients
Peking University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年11月28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
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This study is conducted to evaluate the efficacy and safety of linperlisib combined with CHOP regimen followed by autologous hematopoietic stem cell transplantation and linperlisib monotherapy maintenance for newly diagnosed nTFHL patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed nTFHL classified by WHO-HAEM5, including nodal TFH cell lymphoma, angioimmunoblastic-type, nodal TFH cell lymphoma, follicular-type, Nodal TFH cell lymphoma, NOS
- •Patients planning to receive autologous hematopoietic stem cell transplantation;
- •No previous systemic treatment before enrollment.;
- •There is at least one measurable lesion: the longest diameter (LDi) of the lymph node lesion is greater than 1.5 cm, or the LDi of one extra lymph node lesion is greater than 1 cm (according to the 2014 Lugano classification);
- •Age range from 18 to 65 years old, regardless of gender;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)≤2;
- •Expected survival time≥12 weeks;
- •Adequate bone marrow and organ functions; For female participants of childbearing period, a negative urine or serum pregnancy test should be performed with 1 week prior to receiving first dose of investigational drug (day 1 of cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required.WOCBP subjects and male subjects whose partners are WOCBP should agree to use effective contraception from the time of signing the ICF until 6 months after the last dose of study drug.
- •Adequate organ and bone marrow function without severe hematopoietic abnormalities and abnormal heart, lung, liver, kidney, thyroid function and immunodeficiencies (no blood transfusion, granulocyte colony-stimulating factor or other related medical support within 14 days prior to administration of study drug):
- •Routine blood tests (not transfused, not on granulocyte colony-stimulating factor (G-CSF), not corrected with medication within 14 days prior to screening): hemoglobin (Hb) ≥ 90 g/L; neutrophils (ANC) ≥ 1.5 x 10 9/L; platelets (PLT) ≥ 100 x 109/L;
- •Biochemical tests: TBIL <1.5 × upper limit of normal range (ULN); glutamate alanine aminotransferase (ALT) and glutamate aspartate aminotransferase (AST) ≤2.5 × ULN; serum creatinine (Cr) ≤1.25 × ULN or endogenous creatinine clearance ≥60 mL/min (Cockcroft-Gault formula);
- •Coagulation (unless the subject is receiving anticoagulant therapy and coagulation parameters (PT/INR and APTT) are within the expected range for treatment with anticoagulants at screening): international normalized ratio (INR) ≤ 1.5 x ULN; activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.
- •Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures.
排除标准
- •If a patient has any of the following conditions should not be included in this study:
- •Known allergy to the active ingredients or excipients of linperlisib and CHOP regimens.
- •Patients with factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
- •Medical History and comorbidity
- •The subject had any active, known, or suspected autoimmune disease. Subjects who are in a stable state and do not require systemic immunosuppressive therapy are admitted;
- •Known history of interstitial pneumonia;
- •Current or previous history of other malignancies within 2 years prior to study enrollment.Radically treated basal cell carcinoma of the skin, papillary thyroid carcinoma, squamous skin carcinoma, carcinoma in situ of the breast and carcinoma in situ of the cervix, excepted
- •Received systemic antitumor therapy, including chemotherapy, immunotherapy, and biotherapy (tumor vaccines, cytokines, or growth factors used to control cancer) within 28 days prior to study enrollment.
- •Received autologous or allogeneic hematopoietic stem cell transplantation;
- •Patients with active tuberculosis (TB) should be excluded.
- •Severe acute or chronic infections requiring systemic treatment;
- •Patients with hypertension that is not well controlled with antihypertensive medications (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
- •Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L);
- •Patients with heart failure (New York Heart Association standard Class III or IV), poor coronary artery disease control or arrhythmia, or a history of myocardial infarction within the 6 months prior to screening despite receiving appropriate medication;
- •Had clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline, or vasculitis;
- •Renal failure requiring hemodialysis or peritoneal dialysis;
- •Urine routine indicated urinary protein ≥++, and 24-hour urinary protein quantity > 1.0 g；
- •Patients who have had major surgery or severe trauma have had the effects of the surgery or trauma resolved for less than 28 days prior to enrollment；
- •Complicated interstitial lung disease or history of severely impaired lung function;
- •Patients requiring systemic therapy with corticosteroids (> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to administration of study drug. Inhaled or topical steroids and adrenal hormone replacement at doses > 10 mg/day prednisone efficacy dose are allowed in the absence of active autoimmune disease;
- •Physical and laboratory findings
- •A known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).
- •Active hepatitis [Hepatitis B: Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive and ALT above the upper limit of detection; Hepatitis C: Hepatitis C virus (HCV) ribonucleic acid (RNA) positive and ALT above the upper limit of detection]; co-infection with Hepatitis B and Hepatitis C;
- •Any medical history or disease evidence that may interfere with the study results or other conditions that investigators consider inappropriate for the study.
- •Pregnant or lactating women.
研究组 & 干预措施
linperlisib combined with CHOP regimen
Experimental
干预措施: linperlisib combined with CHOP regimen (Drug)
结局指标
主要结局
progression-free survival
时间窗: 2 year
PFS will be calculated from the start of study drug treatment to the date of disease progression, death, or last follow-up, as appropriate.
次要结局
- ORR(After 6 cycles of induction therapy ，average of 4.2 month and post transplantation)
- CR rate(After 6 cycles of induction therapy ，average of 4.2 month and post transplantation)
- Success rate of stem cell collection(1day before performing an autologous hematopoietic stem cell transplant)
- time to next anti-lymphoma treatment(2 year)
- adverse events(Toxicity will be graded according to the NCI-CTCAC version 4.0, from the first day of the first cycle of induction therapy to 30 days after the last dose of study drug.)
- overall survival (OS)(2 year)
研究者
Jun Zhu
Director
Peking University
研究点 (1)
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