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Copanlisib + Venetoclax for Mantle Cell Lymphoma
Study 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.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT02005471Trial Design
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- 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.
- Group 1: Treatment (copanlisib hydrochloride, venetoclax)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does Copanlisib Hydrochloride have a history of being studied in previous clinical trials?
"Currently, 257 clinical trials are underway to study the effects of Copanlisib Hydrochloride. Out of these ongoing research projects, 32 are in Phase 3. Many of the clinical trials for Copanlisib Hydrochloride originate from Antwerpen and New york; however, there are 9402 locations running trials for Copanlisib Hydrochloride globally."
What conditions has Copanlisib Hydrochloride been proven to be effective against?
"Copanlisib Hydrochloride can be used to effectively treat chronic lymphocytic leukemia (cll), follicular lymphoma, and various other therapeutic procedures."
Are there any available positions for participants in this research project?
"Based on the information available from clinicaltrials.gov, this study is still recruiting patients as of 8/3/2022. The trial began recruitment on 6/29/2022 and plans to enroll 23 individuals total between 2 sites."
What is the sample size for this clinical trial?
"The information on clinicaltrials.gov does show that this trial is currently looking for patients to enroll. The study was posted on 6/29/2022 and updated as recently as 8/3/2022. They are searching for 23 participants from 2 different sites."
Why did researchers design this trial in this way?
"The primary outcome of this clinical trial, which will be evaluated over a Up to end of cycle 2 (1 cycle = 28 days) time frame, is the Overall response rate (Phase II). Secondary outcomes include theOverall survival , which is defined as Will be estimated using the Kaplan-Meier product-limit method along with the Greenwood estimator of standard error; 95% confidence interval for the survival timepoint estimates will be constructed based on the log-log transformation. Median survival time will be estimated when available., and Incidence of adverse events , which is defined as Toxicity and adverse events will be recorded using the NCI"
What is unique about this particular clinical trial?
"There are 257 global trials involving Copanlisib Hydrochloride that are still underway. These studies first started in 2012 and have been conducted across 1508 cities and 53 countries. The initial trial, sponsored by Bayer, was completed in Phase 2 with 227 participants. In the 8 years since then, an additional 70 clinical trials have reached completion."
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