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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)
EU CTIS ID: 2024-517166-42-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 /mm3.
- Hemoglobin ≥ 8 g/dL
- Absolute neutrophil count ≥ 1,500/mm3
You likely can't join if
- 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 Patients permanently withdrawn from study participation will not be allowed to re-enter the study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
See the full eligibility criteria
Who can join
- 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 /mm3.
- 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
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.