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PI3K inhibitor

Copanlisib + Ibrutinib for Central Nervous System Lymphoma

Phase 1 & 2
Waitlist Available
Led By Christian Grommes, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Serum creatinine ≤ 2 times the upper limit of normal
- Creatinine clearance ≥ 30 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing if it's safe to use two drugs, copanlisib and ibrutinib, together to treat people with a brain cancer called PCNSL.

Who is the study for?
Adults with primary central nervous system lymphoma (PCNSL) that's come back or hasn't responded to treatment, or those newly diagnosed but can't have standard chemo. They must be able to handle MRI/CT scans and lumbar punctures, have a life expectancy over 3 months, and good organ function. Contraception is required during the study.Check my eligibility
What is being tested?
The trial tests the safety of combining two drugs, copanlisib and ibrutinib, for treating PCNSL. Participants will receive both medications in an effort to determine how well they work together against this type of lymphoma.See study design
What are the potential side effects?
Possible side effects include high blood sugar levels especially in diabetics; bleeding issues; digestive problems affecting absorption; potential interactions with other drugs like warfarin or certain antiepileptics; risk of infection including HIV/HBV/HCV; heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by creatinine, is within normal limits.
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My kidneys are functioning well enough (creatinine clearance ≥ 30 mL/min).
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My scans or tests show my brain or spinal cancer is getting worse.
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My blood tests show my organs and bone marrow are working well.
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I am 18 years old or older.
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I have PCNSL and cannot have standard chemotherapy, or my PCNSL has returned after treatment.
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I can take care of myself but might not be able to do heavy physical work.
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My hemoglobin is at least 8 g/dL and I haven't had a blood transfusion in the last 2 weeks.
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My bilirubin levels are within the normal range or slightly above.
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I agree to use birth control during and after the study as required.
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I am using or willing to use a highly effective form of birth control.
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I am using contraception or am not of childbearing potential.
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I can undergo spinal taps or Ommaya reservoir procedures.
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I have recovered from side effects of my previous treatment.
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I can provide up to 20 tissue samples from my cancer diagnosis for study.
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I have had a stem cell transplant or brain radiation but can still join the trial.
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My diagnosis of primary central nervous system lymphoma is confirmed by tissue analysis.
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My platelet count is above 75 x 10^9/L without transfusions in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years 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) (phase Ib)
overall response rate (ORR) (phase II)
Secondary outcome measures
To evaluate cerebral spinal fluid (CSF) pharmacokinetics of Copanlisib and Ibrutinib and correlate with plasma pharmacokinetics (phase Ib)
adverse events in terms of incidence and severity (phase Ib and II)
duration of response (DOR) (phase II)
+2 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

1Treatment groups
Experimental Treatment
Group I: Copanlisib in combination with IbrutinibExperimental Treatment2 Interventions
Participants will be assigned to the following dose levels: Dose level 1: Ibrutinib 560 mg daily + Copanlisib 60 mg weekly (3w on/1w off) Dose level 2: Ibrutinib 840 mg daily + Copanlisib 60 mg weekly (3w on/1w off) Dose level -1: Ibrutinib 560 mg daily + Copanlisib 45 mg weekly (3w on/1w off). Phase II: (Simon two-stage design: 14 patients will be treated at the MTD (including 6 patients from the phaseIb portion) If at least 11 patients respond then an additional 19 patients will be accrued to the second stage. Patients in the phase II portion of the trial will receive sequential drug dosing. Patient will be treated in 28-day cycles. During one cycle, only one drug will be administered with a ibrutinib/copanlisib ratio of 1:2. Patients will receive Ibrutinib at 840 mg daily during cycle 1 (day 1 through day 28) (28-day cycles), then copanlisib 60mg weekly on day 1, 8, and 15 during cycle 2 and 3. Patients will then repeat the sequence.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Copanlisib
2016
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,790 Total Patients Enrolled
4 Trials studying Central Nervous System Lymphoma
161 Patients Enrolled for Central Nervous System Lymphoma
Christian Grommes, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
224 Total Patients Enrolled
1 Trials studying Central Nervous System Lymphoma
33 Patients Enrolled for Central Nervous System Lymphoma

Media Library

Copanlisib (PI3K inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03581942 — Phase 1 & 2
Copanlisib (PI3K inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03581942 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has Copanlisib been successful in managing medical conditions?

"Copanlisib is a therapeutically efficacious procedure for treating lymphoma, follicular, and mantle cell (MCL) lymphomas."

Answered by AI

How many venues are currently hosting this clinical experiment?

"At the present moment, this clinical trial is taking place at 7 different sites. These locations are situated in Commack, Uniondale and Montvale as well as 4 other cities. To reduce burdensome transportation needs, prospective participants should take into account their proximity to these centres before enrolling."

Answered by AI

Are there any opportunities for prospective participants to join this experiment?

"The information on clinicaltrials.gov declares that this medical study is presently enlisting participants; the trail was originally published on August 23rd 2018 and has been modified as of July 27th 2022."

Answered by AI

Are there any prior investigations involving Copanlisib?

"The first clinical trials of copanlisib began in 2011 at the National Institutes of Health Clinical Center, 9000 Rockville Pike. To date there have been 116 completed studies and an additional 184 that are active with many being conducted out of Commack, New jersey."

Answered by AI

What is the exact number of participants in this research endeavor?

"Affirmative, the information posted on clinicaltrials.gov certifies that this medical study is actively recruiting patients. Initially published on August 23rd 2018 and recently updated July 27th 2022, the trial requires 45 participants to be recruited from 7 different sites."

Answered by AI
~3 spots leftby Jul 2025