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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
OR
-- Burkitt lymphoma
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
  • B-Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • Germinal Center B-cell Type
  • Burkitt Lymphoma
  • Large B-Cell Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I'm sorry, could you please provide the full criterion? "OR" by itself doesn't provide enough context.
Select...
You have Burkitt lymphoma.
Select...
If you have a history of slow-growing lymphoma, you can still participate in the trial.
Select...
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.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months for 6 months, every 3 months for 2 years, every 6 months for 2 years, then annually for reporting.

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 more

Side effects data

From 2021 Phase 2 trial • 24 Patients • NCT02631590
75%
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%
Creatinine increased
17%
Alkaline phosphatase increased
17%
Sinus tachycardia
17%
Chills
17%
Pain
17%
Thromboembolic event
17%
Dizziness
13%
Generalized muscle weakness
13%
Pain in extremity
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%
Pneumonitis
4%
Sore throat
4%
Productive cough
4%
Cataract
4%
Lung infection
4%
Gastrointestinal disorders -Other
4%
Cholecystitis
4%
Infections and Infestations - Other
4%
Pancreatitis
4%
Toothache
4%
Stomach pain
4%
Nasal congestion
4%
Postnasal drip
4%
Wheezing
4%
Hoarseness
4%
Hepatic infection
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
Doxorubicin
2012
Completed Phase 3
~7940
Vincristine
2003
Completed Phase 4
~2920
Cyclophosphamide
1995
Completed Phase 3
~3780
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
13,609 Previous Clinical Trials
40,915,638 Total Patients Enrolled
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,164 Total Patients Enrolled

Media Library

Copanlisib (PI3K inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04933617 — Phase 1
B-Cell Lymphoma Research Study Groups: 1- Dose Escalation, Original, 2 - Dose Expansion, Modified
B-Cell Lymphoma Clinical Trial 2023: Copanlisib Highlights & Side Effects. Trial Name: NCT04933617 — Phase 1
Copanlisib (PI3K inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04933617 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025