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Venetoclax + Ibrutinib for Chronic Lymphocytic Leukemia
Study Summary
This trial is testing whether adding venetoclax to ibrutinib might help people with CLL or SLL that is not responding or no longer responding to ibrutinib alone.
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 • 201 Patients • NCT03053440Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with CNS lymphoma or leukemia.I have an active hepatitis B or C infection.I have not had a heart attack or significant heart disease in the last 6 months.I have been diagnosed with B cell CLL or SLL and my disease can be measured.I have not had major surgery in the last 4 weeks.My condition did not improve with ibrutinib treatment.I do not have uncontrolled AIHA or ITP.I have no active cancer except for treated skin cancer, cervical carcinoma in situ, or any cancer cured over 3 years ago.I have been diagnosed with HIV.I cannot swallow pills or have a significant gastrointestinal issue.I need blood thinners like warfarin.I am currently on IV antibiotics for an infection.I have severe liver problems.I agree not to become pregnant during the study.I have not had a stroke or brain bleed in the last 6 months.I need treatment with a strong medication that affects liver enzymes.I need urgent treatment to reduce my tumor because of a high risk of tumor breakdown.My blood, liver, and kidney functions are all within normal ranges.My condition worsened while I was on ibrutinib alone.My condition has transformed into a more aggressive form.
- Group 1: venetoclax with high-dose ibrutinib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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 participants is this research endeavor accommodating?
"At present, this trial is not enrolling any participants. The initial post date was May 1st 2018 and the last edit occurred on May 6th 2021. However, there are currently 1523 trials for leukemia and 343 studies involving Ibrutinib that are actively admitting patients."
Has the Food and Drug Administration given its stamp of approval to Ibrutinib?
"Since this is only a Phase 1 trial, suggesting limited evidence regarding efficacy and safety, our team at Power has assigned Ibrutinib a rating of 1."
Have other clinical trials explored the efficacy of Ibrutinib?
"Presently, there are 343 studies actively looking into the possibilities of Ibrutinib with 45 trials in their third phase. Toronto, Ontario is home to a majority of these clinical investigations though 11701 other locations across have been allocated for research as well."
Is the study still open to recruitment?
"Unfortunately, this clinical trial is no longer seeking participants. The study was initially published on May 1st 2018 and last updated six days later. However, there are currently 1523 trials for leukemia patients recruiting volunteers as well as 343 studies involving Ibrutinib that are still enrolling individuals."
To what maladies is Ibrutinib typically prescribed?
"Ibrutinib is an efficacious therapeutic option for patients suffering from Waldenström macroglobulinemia, small lymphocytic lymphoma, or chronic lymphocytic leukemia (CLL)."
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