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PI3K inhibitor
Copanlisib + Venetoclax for Mantle Cell Lymphoma
Phase 1 & 2
Waitlist Available
Led By Alexey Danilov
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Summary
This trial is testing copanlisib and venetoclax as a treatment for mantle cell lymphoma. Copanlisib blocks enzymes needed for cell growth, and venetoclax blocks a protein needed for cancer cell survival.
Who is the study for?
This trial is for adults with mantle cell lymphoma that has returned or isn't responding to treatment. Participants must be able to take pills, have a life expectancy of at least 3 months, and proper organ function. They should not have HIV, hepatitis B or C, uncontrolled diseases like diabetes or heart conditions, and women must not be pregnant.
What is being tested?
The trial is testing the combination of two drugs: Copanlisib Hydrochloride and Venetoclax. It aims to find the safest doses and see how effective they are against relapsed or refractory mantle cell lymphoma by blocking enzymes and proteins cancer cells need to grow.
What are the potential side effects?
Potential side effects may include reactions related to immune system suppression such as infections, liver problems indicated by changes in certain blood tests, fatigue from anemia or other blood-related issues, nausea due to digestive system impact, and possibly increased risk of bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of dose limiting toxicities (Phase I)
Overall response rate (Phase II)
Secondary study objectives
Duration of response
Incidence of adverse events
Overall survival
+3 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Sepsis
11%
SARS-CoV-2 test positive
11%
Abdominal pain
11%
Pneumonia
11%
Rhinovirus infection
11%
COVID-19
11%
Gastroenteritis
11%
Pneumonia pseudomonal
11%
Electrocardiogram QT prolonged
11%
Anaemia
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Febrile neutropenia
11%
Supraventricular tachycardia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (copanlisib hydrochloride, venetoclax)Experimental Treatment2 Interventions
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8, and 15, and venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Copanlisib will be given at 30mg, 45mg, or 60 mg depending on the assigned dose level. Venetoclax will have a weekly dose ramp up from 20mg, 50mg, 100mg, 200mg, and then 400mg thereafter.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2200
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,529 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,992 Total Patients Enrolled
Alexey DanilovPrincipal InvestigatorCity of Hope Medical Cneter
2 Previous Clinical Trials
22 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to swallow pills or take medication by mouth.You must be 18 years old or older.Your doctor believes you will live for at least 3 more months.You have already been treated with venetoclax or other experimental drugs that target BCL2, or with copanlisib.You are able to perform daily activities without being too tired or weak (ECOG score less than or equal to 2).You are allergic to any of the drugs being tested or the ingredients in them.If the doctor thinks that joining the study could be unsafe for you because of any other medical conditions you have.You have prostate cancer that is being monitored without active treatment or with hormonal therapy, and you are not experiencing any symptoms.You had cancer that was completely treated and hasn't come back for at least 2 years.You or your legal representative have given permission to participate in the study and understand what it entails.You are currently participating in another medical study for treatment.You have had a stem cell transplant from another person in the past.You give permission to use tissue samples from a previous biopsy for the study.If you are under 18 years old, you must give your agreement to participate in the study according to the rules of the institution.In case the requirement cannot be met, the study's head researcher may give permission to make an exception.You have a history of non-melanoma skin cancer or a type of melanoma called lentigo maligna, but you have been successfully treated and currently have no signs of the disease.Your cells show specific markers or a genetic mutation that may affect the outcome of the study, as determined by laboratory tests.Your previous treatment for the condition did not work or your condition has worsened despite treatment.You have received treatment in the past for MCL, either through chemotherapy or targeted therapy for at least 2 cycles.You had cancer before, but certain types of prior cancer are allowed.I'm sorry, but I need more information to accurately summarize this criterion. Can you please provide me with the list of interventions that are mentioned?You cannot be taking high doses of corticosteroids (a type of medication) every day. Using corticosteroids in the form of creams or inhalers is allowed.You cannot take certain medications or foods that affect the way your body processes the study drug for a week before starting the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (copanlisib hydrochloride, venetoclax)
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.
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