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BTK inhibitor

Copanlisib for Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Led By Jennifer Crombie, MD
Research Sponsored by Inhye Ahn, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to understand and the willingness to sign a written informed consent document
Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma as per 2018 IWCLL criteria with evidence of persistent disease, defined as measurable adenopathy or splenomegaly, circulating disease, or marrow disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is studying the effects of adding copanlisib to ibrutinib or acalabrutinib in people with CLL that has returned or does not respond to treatment.

Eligible Conditions
  • Chronic Lymphocytic Leukemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Complete response (CR) Rate
Secondary outcome measures
Duration of Response (DOR)
Therapeutic procedure
Overall Survival (OS)
+1 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%
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%
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

1Treatment groups
Experimental Treatment
Group I: Addition of copanlisib to either ibrutinib or acalabrutinibExperimental Treatment3 Interventions
During the 28-day study treatment cycles, participants will: Continue to take ibrutinib (daily) or acalabrutinib (twice a day) at a predetermined dose for as long as there are no serious side effects and disease progression Receive intravenous infusion of copanlisib at a predetermined dose days 1, 8 and 15 for cycles 1-6.
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
Acalabrutinib
FDA approved

Find a Location

Who is running the clinical trial?

Inhye Ahn, MDLead Sponsor
Dana-Farber Cancer InstituteLead Sponsor
1,077 Previous Clinical Trials
340,733 Total Patients Enrolled
Inhye AhnLead Sponsor

Frequently Asked Questions

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

How hazardous is the application of Copanlisib for medicinal purposes?

"Copanlisib was evaluated as a 2 on our safety scale due to the lack of efficacy data despite supporting evidence for its safety in Phase 2 trials."

Answered by AI

Are there any vacancies for prospective volunteers in this experiment?

"According to information on clinicialtrials.gov, this research study is actively recruiting participants and has been since it was posted in February of 2021 with its latest update being November 15th 2022."

Answered by AI

How many participants are currently taking part in this clinical experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial is actively seeking volunteers and was initially posted on February 18th 2021. The study requires 30 patients from a single medical centre for participation."

Answered by AI

What medical conditions is Copanlisib typically used to treat?

"Copanlisib is a therapeutic procedure used to treat lymphoma, follicular and mantle cell lymphomas (MCLs), as well as Waldenstrom macroglobulinemia."

Answered by AI
~0 spots leftby Mar 2025