Copanlisib for Acute Lymphoblastic Leukemia

Duke Cancer Center, Durham, NC
Acute Lymphoblastic LeukemiaCopanlisib - Drug
Eligibility
18+
All Sexes

Study Summary

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

Eligible Conditions
  • Acute Lymphoblastic Leukemia

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase < 1

Similar Trials

1
Marqibo
1
Copanlisib
1
Copanlisib

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 1 year

1 year
Doxycycline
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).

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Marqibo
1
Copanlisib
1
Copanlisib

Side Effects for

Combination Therapy
75%Lymphocyte count decreased
75%Platelet count decreased
71%White blood cell decreased
71%Fatigue
67%Anemia
67%Neutrophil count decreased
63%Hypertension
54%Hyperglycemia
50%Nausea
46%Lipase increased
46%Diarrhea
46%Anorexia
42%Abdominal Pain
42%Alanine aminotransferase increased
33%Fever
29%Hyponatremia
25%Hypotension
25%Rash maculo-papular
25%Vomiting
25%Hyperkalemia
25%Weight loss
25%Dehydration
25%Constipation
21%Aspartate aminotransferase increased
21%Edema limbs
21%Serum amylase increased
17%Pain
17%Creatinine increased
17%Thromboembolic event
17%Alkaline phosphatase increased
17%Chills
17%Sinus tachycardia
17%Dizziness
13%Generalized muscle weakness
13%Blood bilirubin increased
13%Non-cardiac chest pain
13%Urinary tract infection
13%Mucositis oral
13%Tinnitus
13%Infusion related reaction
13%Pain in extremity
13%Dyspnea
13%Gastrointestinal disorders - Other
13%Upper respiratory infection
13%Anxiety
13%Hypoalbuminemia
13%Sepsis
8%Insomnia
8%Pruritus
8%Abdominal distension
8%Rash acneiform
8%Bloating
8%Cough
8%Back pain
8%Ascites
8%Neck pain
8%Pleural effusion
8%Dysphagia
8%Depression
8%Hypoxia
8%Gallbladder obstruction
8%General disorders and administration site conditions -Other
8%Infections and infestations - Other
8%Dysgeusia
8%Peripheral sensory neuropathy
4%Blood antidiuretic hormone abnormal
4%Hypercalcemia
4%Productive cough
4%Bone pain
4%Injury, poisoning and procedural complications - Other
4%Cystitis noninfective
4%Ear pain
4%Cataract
4%Dry eye
4%Epistaxis
4%Investigations - Other
4%Urine output decreased
4%Hypernatremia
4%Phlebitis
4%Musculoskeletal and connective tissue disorders - Other
4%Gallbladder infection
4%Sinus bradycardia
4%Hoarseness
4%Hepatic infection
4%Dry mouth
4%Skin and subcutaneous tissue disorders - Other
4%Hematuria
4%Urine discoloration
4%Hypokalemia
4%Confusion
4%Activated partial thromboplastin time prolonged
4%Atelectasis
4%Stomach pain
4%Skin ulceration
4%Nasal congestion
4%Dry skin
4%Cholecystitis
4%Malaise
4%Gastroesophageal reflux disease
4%Acute kidney injury
4%Urinary tract obstruction
4%Pancreatitis
4%Toothache
4%Postnasal drip
4%Pericarditis
4%Fracture
4%Neoplasms benign, malignant and unspecified - Other
4%Sore throat
4%Paroxysmal atrial tachycardia
4%Colitis
4%Colonic obstruction
4%Infusion site extravasation
4%Pneumonitis
4%Wheezing
4%Renal and urinary disorders - Other
4%Hyperuricemia
4%Hypomagnesemia
4%Aspiration
4%Hiccups
4%Gait disturbance
4%Gastrointestinal disorders -Other
4%Infections and Infestations - Other
4%Lung infection
4%Headache
4%Parathesia
4%Venous injury
4%Allergic reaction
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02631590) in the Combination Therapy ARM group. Side effects include: Lymphocyte count decreased with 75%, Platelet count decreased with 75%, White blood cell decreased with 71%, Fatigue with 71%, Anemia with 67%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1 Treatment Group

Copanilisib
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Copanlisib · No Placebo Group · Phase < 1

Copanilisib
Drug
Experimental Group · 1 Intervention: Copanlisib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copanlisib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

BayerIndustry Sponsor
2,174 Previous Clinical Trials
24,087,668 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

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top