2024-517166-42-00已完成2 期
A prospective multicenter phase 2 study of copanlisib in combination with rituximab and CHOP chemotherapy (COPA-R-CHOP) in patients with previously untreated diffuse large B-cell lymphoma (DLBCL)
Universitaetsklinikum Muenster AöR13 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2024年9月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 13
- 主要终点
- Safety run-in part: The primary endpoint is the recommended phase 2 dose after analysis of the first 12 patients treated. All patients: 2-year PFS with 95% CI of all patients treated.
研究概览
简要总结
The primary objective with respect to safety is the rate of patients with dose-limiting toxicity during cycle 1 of R-CHOP and copanlisib. The primary efficacy objective is to estimate the 2-year PFS with 95% CI achieved with copanlisib in combination with R-CHOP in newly diagnosed DLBCL patients (18-80 years) and an IPI 2 - 5.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed DLBCL (NOS) or High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements or High-grade B-cell lymphoma (NOS) or Follicular lymphoma Grad 3B (primary diagnosis without history of indolent lymphoma)
- •GFR ≥ 40 mL/min/1.73 m2 according to the CKD-EPI Creatinine Equation (2009)
- •INR and PTT ≤ 1.5 x ULN
- •Platelet count ≥ 75,000 /mm
- •Hemoglobin ≥ 8 g/dL
- •Absolute neutrophil count ≥ 1,500/mm3
- •Left ventricular ejection fraction ≥ 50%
- •No prior lymphoma therapy
- •Ability to understand and willingness to sign written informed consent. Signed informed consent must be obtained before any study specific procedure
- •18-80 years of age
- •International Prognostic Index (IPI) 2-5
- •toxicity and response criteria of the eastern cooperative oncology group (ECOG) 0-2
- •Life expectancy of at least 3 months
- •Women of childbearing potential and men must agree to use effective contraception when sexually active.
- •Total bilirubin ≤ 1.5 x ULN (< 3 x ULN for patients with Gilbert syndrome, patients with cholestasis due to compressive adenopathies of the hepatic hilum or documented liver involvement or with biliary obstruction due to lymphoma)
- •ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement by lymphoma)
- •Lipase ≤ 1.5 x ULN
排除标准
- •Previous assignment to treatment during this study. Patients permanently withdrawn from study participation will not be allowed to re-enter the study
- •Previous or concurrent history of malignancies within 5 years prior to study treatment except for curatively treated: Cervical carcinoma in situ, Non-melanoma skin cancer, Superficial bladder cancer (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria]), Localized prostate cancer
- •Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of study medication
- •Patients with seizure disorder requiring medication
- •Proteinuria of ≥ CTCAE Grade 3 as assessed by a 24h protein quantification or estimated by urine protein: creatinine ratio > 3.5 on a random urine sample
- •Concurrent diagnosis of pheochromocytoma
- •Congestive heart failure > New York Heart Association (NYHA) class 2
- •Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
- •Myocardial infarction less than 6 months before start of test drug
- •Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before the start of study medication
- •Non-healing wound, ulcer, or bone fracture
- •Previous (within 28 days or less than 5 half-lives of the drug before start of study treatment) or concomitant participation in another clinical study with investigational medicinal product(s)
- •Active, clinically serious infections > CTCAE Grade 2
- •Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
- •Known history of drug induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, on-going extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver or portal hypertension
- •Ongoing inflammatory bowel disease
- •History of, or current autoimmune disease
- •Prior treatment with PI3K inhibitors
- •Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent
- •Patient is pregnant (β-HCG positive) or breast-feeding
- •Known hypersensitivity to copanlisib or to any of the excipients of rituximab, cyclophosphamide, doxorubicin, vincristine, and/or prednisone
- •Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent persons (e.g. employee or student of the investigational site)
- •Type I or II diabetes mellitus with HbA1c > 8.5% at screening or fasting plasma glucose > 160 mg/dL at screening
- •History or concurrent condition of interstitial lung disease and/or severely impaired lung function (as judged by the investigator)
- •Known lymphoma involvement of the central nervous system
- •HIV infection
- •HBV and HCV infection. Patients with serologic markers of HBV immunization due to vaccination (HBsAg negative, Anti-HBc negative and Anti-HBs positive) will be eligible
- •CMV-PCR positive at baseline
结局指标
主要结局
Safety run-in part: The primary endpoint is the recommended phase 2 dose after analysis of the first 12 patients treated. All patients: 2-year PFS with 95% CI of all patients treated.
Safety run-in part: The primary endpoint is the recommended phase 2 dose after analysis of the first 12 patients treated. All patients: 2-year PFS with 95% CI of all patients treated.
次要结局
- Secondary endpoints for efficacy: OS, EFS, CR, PR, ORR, PD, DOR, rate of relapse, Outcome in molecular subtypes of DLBCL
- Secondary endpoints for safety: Adverse events (AE), Serious AEs (SAE), Number of treatment related deaths, Incidence of secondary malignancies, Number and duration of therapy cycles, Cumulative doses of cyclophosphamide, doxorubicin, vincristine, rituximab and copanlisib
研究者
Central study office
Scientific
Universitaetsklinikum Muenster AöR
研究点 (13)
Loading locations...
相似试验
招募中
1 期
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)NCT07260812TCRx Therapeutics Co.Ltd18
招募中
3 期
A study to compare how well odronextamab combined with chemotherapy works and how safe it is against rituximab combined with chemotherapy, in patients with previously untreated diffuse large B-cell lymphoma2022-502785-25-00Regeneron Pharmaceuticals Inc.419
招募中
1 期
A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal SprayNCT07259538VivaVision Biotech, Inc60
招募中
1 期
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid TumorsColorectal CancerNon-Small Cell Lung CancerNCT07261631Novartis Pharmaceuticals180
进行中（未招募）
1/2 期
A clinical trial to evaluate the safety and effectiveness of a combination of either AG-12or AG-221 tablets with azacitidine injections in patients withnewly diagnosed Acute Myeloid Leukemia (AML) and who have mutations in enzymes isocitrate dehydrogenase 1 or 2 (IDH 1 or IDH2) and are not candidates to receive intensive induction chemotherapy.2024-511722-31-00Celgene Corp.70