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Venetoclax for Anaplastic Lymphoma
Study Summary
This trial looks at the side effects and best dose of two drugs, venetoclax and romidepsin, to treat patients with a type of lymphoma that has come back or does not respond to treatment.
- Anaplastic Lymphoma
- T-Cell and NK-Cell Non-Hodgkin Lymphoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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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Who is running the clinical trial?
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- You have another type of cancer that needs to be treated right now.You have taken medications that can interfere with the study drug within a week before starting the study.You have not taken any experimental drugs or used experimental medical devices within the past 21 days before starting the study treatment.You have moderate to severe congestive heart failure according to the New York Heart Association classification.You have difficulty swallowing capsules or have a condition that affects your ability to absorb nutrients from your intestines.You are willing to give a small sample of your tissue for testing.You have tried and did not respond well to at least two different treatments before. If you have a specific type of lymphoma called anaplastic large cell lymphoma, one of the treatments you tried must have been brentuximab vedotin and it didn't work or caused severe side effects.
- Group 1: Treatment (venetoclax, romidepsin)
- 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
How many people are being given the opportunity to participate in this clinical trial?
"Unfortunately, this study is not currently looking for new participants. Although, it is worth noting that the trial was first posted on 8/21/2018 and was most recently updated on 7/26/2022. Additionally, if you are exploring other studies, there are presently 1808 trials actively recruiting participants with recurrent mature t- cell and nk-cell non-hodgkin lymphoma and 243 trials for Venetoclax actively recruiting participants."
Have patients undergone this kind of treatment before?
"Celgene Corporation's Venetoclax has been involved in 659 trials since it first began Phase 1 drug approval in 2012. Out of those, 243 are still considered active studies spread across 1218 cities and 46 countries."
Is Venetoclax a common medication in research trials?
"Originally, Venetoclax was studied in 2012 by the research team at Johns Hopkins University/Sidney Kimmel Cancer Center. Since that initial exploration, there have been a total of 659 completed clinical trials. Right now, 243 different venetoclax trials are actively recruiting patients; many of these studies are based in Omaha, Nebraska."
What goals does this clinical trial hope to achieve?
"The purpose of this study, which will last for up to two years, is to track the number of adverse events. Additionally, researchers will be measuring 'time to response' and 'complete response rate' in order to better understand the efficacy of the medication being trialed. Lastly, they will also be studying overall survival rates."
What is the FDA's current stance on Venetoclax?
"While there is some data supporting Venetoclax's safety, it only received a score of 2 because this is still early in the clinical trial process."
Are there any remaining subject positions available for this research?
"This particular clinical trial is no longer looking for participants. However, if you are still interested in finding a study, there are 1808 other trials actively recruiting patients with recurrent mature t- cell and nk-cell non-hodgkin lymphoma and 243 studies involving Venetoclax that are currently enrolling patients."
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