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PI3K inhibitor
Copanlisib + Rituximab for Follicular Lymphoma
Phase 2
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
Adequate organ function as evidenced by specific laboratory parameters
ECOG performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 months from study enrollment
Awards & highlights
Study Summary
This trial is studying if a combination of drugs can attack the cancer cells in people with follicular lymphoma.
Who is the study for?
This trial is for people with untreated Follicular Lymphoma (FL) who need systemic therapy due to symptoms or disease progression. Participants must be at least 8 years old, have good organ function, and not have had previous FL treatments except radiation. They should also agree to use effective contraception.Check my eligibility
What is being tested?
The study tests the effectiveness of copanlisib plus rituximab in slowing FL growth. It involves up to 13 cycles of treatment over 28 days each, with both drugs administered through IV infusions at varying intervals.See study design
What are the potential side effects?
Potential side effects include reactions related to IV infusion, changes in blood counts that could affect immunity and clotting, liver enzyme alterations suggesting liver stress or damage, and possible kidney function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organ functions are within normal ranges according to recent tests.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
My lymphoma is confirmed as grade 1-2 or 3a Follicular Lymphoma by NCI standards.
Select...
I am at least 8 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 30 months from study enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 months from study enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acheivement of complete response
Secondary outcome measures
Continuous complete response rate
Safety of study treatments when given in combination
Side effects data
From 2021 Phase 2 trial • 24 Patients • NCT0263159075%
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%
Cataract
4%
Lung infection
4%
Gastrointestinal disorders -Other
4%
Cholecystitis
4%
Infections and Infestations - Other
4%
Pancreatitis
4%
Toothache
4%
Stomach pain
4%
Postnasal drip
4%
Wheezing
4%
Hoarseness
4%
Hepatic infection
4%
Productive cough
4%
Nasal congestion
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: 1Experimental Treatment2 Interventions
Window of treatment with Copanlisib 60mg via IV for a single 28 day cycle, once weekly for the first 3 weeks and then a 1 week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m2 via IV, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copanlisib
2016
Completed Phase 2
~130
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,312 Total Patients Enrolled
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,142 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymphoma has spread to my brain or spinal cord.My diabetes is not under control despite taking my medication.I have not had a stroke or mini-stroke in the last 3 months.My organ functions are within normal ranges according to recent tests.I can take care of myself and am up and about more than half of the day.I have had a heart attack in the last 6 months.I have FL and haven't had chemo, targeted therapy, or antibody treatment before copanlisib, but may have had radiation over 12 weeks ago.I am currently receiving treatment for another cancer.I have severe liver problems.I have been treated for an autoimmune disease in the last year.I agree to use birth control while in the study.My cancer is between stage II and IV, or I had stage I and it returned after radiation.I have an active hepatitis B infection.I have unstable chest pain.My lymphoma is confirmed as grade 1-2 or 3a Follicular Lymphoma by NCI standards.I am not on any medication that this trial does not allow.I need urgent treatment to reduce my tumor because it's affecting my organ function.I do not have HIV or any other immune deficiency.I meet the requirements for starting treatment for my condition.I have enough biopsy tissue available for further study.I have had lung inflammation treated with steroids, or I currently have lung disease.I have an active hepatitis C infection.I haven't had major surgery or a serious injury recently.I am at least 8 years old.My heart condition does not severely limit my daily activities.My high blood pressure is not controlled despite taking medication.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the US Food and Drug Administration sanctioned Copanlisib?
"Considering there is available evidence attesting to the safety of Copanlisib, yet no proof for efficacy, our team at Power has assigned a score of 2 to this drug."
Answered by AI
For which conditions is Copanlisib prescribed?
"Copanlisib is an effective method of treating DLBCL, B-cell lymphomas, and polyangium."
Answered by AI
Is this study open to new enrollees?
"Yes, the data hosted on clinicaltrials.gov affirms that this study is current looking to enroll patients. The research was first initiated on August 22nd 2019 and its most recent update took place on October 15th 2022. To participate in the trial, 65 people need to be recruited from one medical centre."
Answered by AI
What is the total sample size of this clinical trial?
"Affirmative. Information available on clinicaltrials.gov demonstrates that this medical investigation, first posted in August 22nd 2019 and recently revised in October 15th 2022, is actively searching for patients; 65 individuals need to be recruited from 1 location."
Answered by AI
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