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Acalabrutinib + Obinutuzumab for Chronic Lymphocytic Leukemia
Study Summary
This trial will study whether it is safe to stop treatment with acalabrutinib and obinutuzumab after the cancer responds to the treatment, followed by a period of observation.
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 2020 Phase 2 trial • 177 Patients • NCT04346199Trial Design
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- You must use a highly effective method of birth control, such as a tubal ligation, vasectomy, birth control pills that prevent ovulation, hormonal intrauterine devices, or copper intrauterine devices.I am 18 years old or older.My bilirubin levels are within normal limits, or I have a condition that explains higher levels.I will use protection or abstain from sex to prevent pregnancy during and 6 months after treatment.I do not have active bleeding or a bleeding disorder like von Willebrand's disease or hemophilia.My hemoglobin level is at least 8 g/dL without needing a blood transfusion.You have taken any experimental medication within the last month, or within five half-lives of the medication, whichever is shorter.I am a man who will not have unprotected sex or donate sperm for 6 months after my last dose.I am a woman who can still have children.I understand that periodic abstinence and withdrawal are not accepted as contraception methods for this trial.Women cannot donate their eggs during the study.I have received treatment for CLL before, not counting steroids for other reasons.My blood clotting tests are within normal limits, or only high due to my blood thinner medication.I have untreated CLL or SLL and need treatment according to guidelines.My physical ability hasn't worsened in the last 2 weeks.My platelet count is adequate without needing a transfusion.You have had cancer in the past, except for some types that were treated and have not come back for at least three years. You are allowed to participate if you have a specific type of leukemia or a history of a rare condition called PML. However, you will be excluded if you are allergic to any of the study drugs.
- 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
Given its side effects, is Acalabrutinib still an effective medication?
"The Power team rates the safety of Acalabrutinib as a 2. This is because it is a phase 2 trial, which means that there is some data supporting its safety, but none indicating whether or not it is effective."
Is there extensive research available on Acalabrutinib?
"Acalabrutinib was first studied in 2012 at CHU de Dijon. Since then, a total of 79 trials have been completed with 167 more currently underway. A large portion of these active studies are based in Commack, New york."
How many people are being signed up for this clinical trial?
"This specific trial is not recruiting at the moment, as the last update was on November 9th, 2022. However, there are 355 clinical trials for small lymphocytic lymphoma and 167 trials for Acalabrutinib that are actively recruiting participants."
In how many hospitals is this research being conducted?
"To make participating in this study as convenient as possible for patients, recruitment is happening at 8 different locations. While some of these sites are in Commack, Harrison and Basking Ridge, there are also 5 other centres."
Are patients still being enrolled in this program?
"This study has already stopped recruiting patients. The trial was first advertised on May 21st, 2021 and the most recent update to the posting was on November 9th, 2022. However, there are still many other opportunities for small lymphocytic lymphoma patients as there are 355 clinical trials currently searching for volunteers. For those interested in Acalabrutinib specifically, 167 studies are actively looking for participants."
What are the primary benefits of Acalabrutinib?
"Acalabrutinib is not only effective in the treatment of mantle cell lymphoma (MCL), but also for other cancers such as refractory follicular lymphoma, small lymphocytic lymphoma, and chronic lymphocytic leukemia (CLL)."
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