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PI3K Inhibitor

Copanlisib for Acute Lymphoblastic Leukemia

Phase < 1
Waitlist Available
Led By Dorothy Sipkins, MD
Research Sponsored by Dorothy Sipkins, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Relapsed/refractory, Philadelphia chromosome positive or negative, B-cell, adult (≥ age 18) acute lymphoblastic leukemia (including bone marrow, extramedullary, CNS disease, or all), with or without prior hematopoietic stem cell transplant.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will study how well a drug called copanlisib works in patients with relapsed or refractory B-ALL.

Who is the study for?
Adults (18+) with relapsed/refractory B-cell acute lymphoblastic leukemia, including those who've failed all FDA-approved tyrosine kinase inhibitors or can't take them. Participants need decent kidney function, acceptable liver enzymes levels, and if they have lung disease, adequate lung capacity. They shouldn't have other active cancers needing treatment (with some exceptions), uncontrolled infections or diseases like type 1 diabetes, untreated HIV, active hepatitis B/C, severe GVHD from stem cell transplant or need immediate cancer reduction therapy.Check my eligibility
What is being tested?
The trial is testing the effect of a single dose of Copanlisib on biological markers in leukemia cells before starting salvage induction therapy in patients with relapsed/refractory B-cell ALL. It aims to enroll about 10 participants to assess how their leukemia responds at this early stage.See study design
What are the potential side effects?
While not explicitly listed here for Copanlisib in this context, common side effects may include high blood pressure, nausea and vomiting; less commonly it could affect blood sugar levels and cause rash or serious infections due to immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are an adult (18 years or older) with B-cell acute lymphoblastic leukemia that has come back or is not responding to treatment. This includes leukemia in the bone marrow, other parts of the body, or the central nervous system. You may or may not have had a previous stem cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Doxycycline
Secondary outcome measures
Evaluate the effect of copanlisib exposure on proliferation of ALL blasts as determined by flow cytometric blast cell Ki-67 index.
Evaluate the effect of copanlisib exposure on proliferation of ALL blasts as determined by peripheral blood hematologic parameters (CBC and WBC differential including blast percentage).

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: CopanilisibExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copanlisib
2016
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

BayerIndustry Sponsor
2,229 Previous Clinical Trials
25,325,434 Total Patients Enrolled
Dorothy Sipkins, MD, PhDLead Sponsor
1 Previous Clinical Trials
Dorothy Sipkins, MD5.01 ReviewsPrincipal Investigator - Duke University
Duke University
1 Previous Clinical Trials

Media Library

Copanlisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04803123 — Phase < 1
Acute Lymphoblastic Leukemia Research Study Groups: Copanilisib
Acute Lymphoblastic Leukemia Clinical Trial 2023: Copanlisib Highlights & Side Effects. Trial Name: NCT04803123 — Phase < 1
Copanlisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04803123 — Phase < 1

Frequently Asked Questions

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

Is this experiment pioneering a new approach to treatment?

"Since 2012, Bayer has sponsored research into copanlisib. After the first study in that year with 227 participants, it was given Phase 2 drug approval. Nowadays, there are 32 active trials of this medication across 983 cities and 46 countries."

Answered by AI

Are there any prior experimental findings concerning Copanlisib?

"Currently, there are 32 studies that focus on Copanlisib with two of them in their terminal stage. Most trials for the drug take place in Houston, Texas yet an additional 2118 sites worldwide host experiments regarding its efficacy."

Answered by AI

Is this experiment presently open to participating subjects?

"Affirmative. According to the information on clinicaltrials.gov, recruitment for this research project is still in progress after being initially posted on June 21st 2021 and last updated on June 28th 2022. The study requires 10 volunteers from a single site."

Answered by AI

What population is participating in the experiment?

"Affirmative. According to the information on clinicaltrials.gov, this research endeavour is currently recruiting participants after being first posted on June 21st 2021 and last updated on June 28th 2022. This trial requires a total of 10 patients from 1 medical centre for enrolment."

Answered by AI
~1 spots leftby Mar 2025