Your session is about to expire
← Back to Search
PI3K inhibitor
Copanlisib + EPOCH-R for High-Grade B-cell Lymphoma
Phase 1
Waitlist Available
Led By Mark J Roschewski, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 months for 6 months, every 3 months for 2 years, every 6 months for 2 years, then annually
Awards & highlights
Study Summary
This trial tests if a combo of drugs can help treat aggressive B-cell lymphomas. Eligible participants must be 18+. Screening tests & tissue/fluid samples will be collected. Treatment given in 21-day cycles, followed by at least 5 yrs of follow-up.
Eligible Conditions
- Germinal Center B-cell Type
- B-Cell Lymphoma
- Non-Hodgkin's Lymphoma
- Burkitt Lymphoma
- Large B-Cell Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 2 months for 6 months, every 3 months for 2 years, every 6 months for 2 years, then annually
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months for 6 months, every 3 months for 2 years, every 6 months for 2 years, then annually
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) and Recommended Phase II dose (RP2D)
Secondary outcome measures
Complete Response Rate
Event-free survival (EFS)
Overall Response Rate
+3 moreSide effects data
From 2021 Phase 2 trial • 24 Patients • NCT0263159075%
Platelet count decreased
75%
Lymphocyte count decreased
71%
White blood cell decreased
71%
Fatigue
67%
Neutrophil count decreased
67%
Anemia
63%
Hypertension
54%
Hyperglycemia
50%
Nausea
46%
Lipase increased
46%
Diarrhea
46%
Anorexia
42%
Alanine aminotransferase increased
42%
Abdominal Pain
33%
Fever
29%
Hyponatremia
25%
Hyperkalemia
25%
Constipation
25%
Vomiting
25%
Weight loss
25%
Dehydration
25%
Hypotension
25%
Rash maculo-papular
21%
Serum amylase increased
21%
Aspartate aminotransferase increased
21%
Edema limbs
17%
Alkaline phosphatase increased
17%
Creatinine increased
17%
Sinus tachycardia
17%
Chills
17%
Pain
17%
Thromboembolic event
17%
Dizziness
13%
Pain in extremity
13%
Generalized muscle weakness
13%
Gastrointestinal disorders - Other
13%
Mucositis oral
13%
Anxiety
13%
Tinnitus
13%
Infusion related reaction
13%
Non-cardiac chest pain
13%
Blood bilirubin increased
13%
Hypoalbuminemia
13%
Dyspnea
13%
Sepsis
13%
Upper respiratory infection
13%
Urinary tract infection
8%
Back pain
8%
Neck pain
8%
Depression
8%
Gallbladder obstruction
8%
Abdominal distension
8%
Ascites
8%
Bloating
8%
Dysphagia
8%
General disorders and administration site conditions -Other
8%
Cough
8%
Hypoxia
8%
Pleural effusion
8%
Pruritus
8%
Rash acneiform
8%
Infections and infestations - Other
8%
Insomnia
8%
Dysgeusia
8%
Peripheral sensory neuropathy
4%
Postnasal drip
4%
Cataract
4%
Lung infection
4%
Infections and Infestations - Other
4%
Pancreatitis
4%
Toothache
4%
Stomach pain
4%
Wheezing
4%
Hoarseness
4%
Hepatic infection
4%
Productive cough
4%
Gastrointestinal disorders -Other
4%
Sore throat
4%
Cholecystitis
4%
Nasal congestion
4%
Pneumonitis
4%
Urinary tract obstruction
4%
Bone pain
4%
Musculoskeletal and connective tissue disorders - Other
4%
Gallbladder infection
4%
Paroxysmal atrial tachycardia
4%
Pericarditis
4%
Sinus bradycardia
4%
Ear pain
4%
Dry eye
4%
Fracture
4%
Neoplasms benign, malignant and unspecified - Other
4%
Colitis
4%
Colonic obstruction
4%
Dry mouth
4%
Gastroesophageal reflux disease
4%
Infusion site extravasation
4%
Malaise
4%
Activated partial thromboplastin time prolonged
4%
Blood antidiuretic hormone abnormal
4%
Investigations - Other
4%
Urine output decreased
4%
Hypercalcemia
4%
Hypernatremia
4%
Hyperuricemia
4%
Hypokalemia
4%
Hypomagnesemia
4%
Phlebitis
4%
Aspiration
4%
Atelectasis
4%
Epistaxis
4%
Hiccups
4%
Dry skin
4%
Skin and subcutaneous tissue disorders - Other
4%
Skin ulceration
4%
Confusion
4%
Acute kidney injury
4%
Cystitis noninfective
4%
Hematuria
4%
Renal and urinary disorders - Other
4%
Urine discoloration
4%
Injury, poisoning and procedural complications - Other
4%
Gait disturbance
4%
Headache
4%
Parathesia
4%
Venous injury
4%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Therapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2 - Dose Expansion, ModifiedExperimental Treatment7 Interventions
Copanlisib (IV) at the RP2D or MTD on day 1 of each 21-day cycle in combination with standard dosing DA-EPOCH-R. Up to 6 cycles total.
Group II: 1- Dose Escalation, OriginalExperimental Treatment7 Interventions
Copanlisib (IV) per dose level (30 mg, 45 mg, or 60 mg) on day 1 of each 21-day cycle in combination with standard dosing DA-EPOCH-R to determine RP2D and MTD of copanlisib. Up to 6 cycles total.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Cyclophosphamide
1995
Completed Phase 3
~3770
Doxorubicin
2012
Completed Phase 3
~7940
Vincristine
2003
Completed Phase 4
~2910
Rituximab
1999
Completed Phase 4
~1880
Etoposide
2010
Completed Phase 3
~2440
Copanlisib
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,680 Previous Clinical Trials
40,928,511 Total Patients Enrolled
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,156 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tried or cannot take medications called PI3K inhibitors.You have severe congestive heart failure (classified as III-IV by the New York Heart Association).You have unstable chest pain (angina).You or your family have a history of long QT syndrome or sudden death.You are taking medications that are not allowed in the study.You have Burkitt lymphoma.If you have a history of slow-growing lymphoma, you can still participate in the trial.You may experience temporary nausea, vomiting, or fever, but if you have ongoing symptoms like stomach pain, tenderness, rash, or high levels of white blood cells called eosinophilia, you cannot participate in the study.I'm sorry, could you please provide the full criterion? "OR" by itself doesn't provide enough context.You have an ongoing medical condition that could affect the study results or put you at risk, as decided by the doctor in charge of the study.You have a heart condition that is not under control and could cause significant health problems. This includes irregular heartbeats, heart disease, or other heart-related issues.You or someone in your family have a heart condition called long QT syndrome or a history of sudden unexplained deaths.You have a condition, either physical or mental, that may make it difficult to follow the requirements of the study or affect the accuracy of the study's results.
Research Study Groups:
This trial has the following groups:- Group 1: 1- Dose Escalation, Original
- Group 2: 2 - Dose Expansion, Modified
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger