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Combination Therapy for Chronic Lymphocytic Leukemia
Study Summary
This trial is studying ibrutinib, obinutuzumab, and venetoclax to treat patients with chronic lymphocytic leukemia.
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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- I am not currently using corticosteroids, or only using low doses for non-blood related conditions.I do not have any other active cancer besides the one being treated.I have been diagnosed with CLL or SLL.I haven't received specific drug treatments for my CLL or SLL.I have severe heart failure.My stomach and intestines work normally.I am between 18 and 70 years old.I do not have an active blood disorder that destroys red blood cells and requires treatment to suppress my immune system.I haven't needed high dose steroids for autoimmune issues.I haven't had major surgery in the last 4 weeks or minor surgery in the last 3 days.I can swallow pills.I have not had a heart attack or severe heart issues in the last 6 months.I haven't had any infections needing treatment in the last 14 days.I have not had a stroke or brain bleed in the last 6 months.I have an ongoing hepatitis C infection.I am taking medication that strongly affects liver enzyme activity.I have received steroids for cancer treatment within the last week.I haven't taken strong or moderate CYP3A affecting drugs in the last week.I have taken warfarin or similar medication in the last 30 days.I haven't taken immunosuppressants, except steroids, in the last 28 days.I have not received any live vaccines in the last 4 weeks.I have a bleeding disorder or hemophilia.I have a serious liver condition right now.I have worsening bone marrow failure or symptoms due to enlarged lymph nodes, spleen, or liver.I am able to get out of my bed or chair and move around.I have been evaluated for my ability to move and for other health conditions.My lymphocytes are a specific type that have certain markers (CD19, CD20, CD23, and CD5) but not others (CD3, CD2).I have had a fever over 100.5°F for 2 weeks without an infection.My blood tests show worsening anemia or low platelets.I have small lymphocytic lymphoma or my blood lymphocyte count is high.My tests for a specific genetic marker in my cancer (t(11;14)) are negative.I experience moderate to severe tiredness due to my CLL.My cancer shows specific protein markers.I have symptoms or worsening swelling of lymph nodes, spleen, or liver.My kidney function is good, with a GFR over 40 mL/min.I can take medication to prevent tumor lysis syndrome.I have not had radiation therapy in the last 4 weeks.My genetic test shows no deletion on chromosome 17.My blood cancer type matches CLL.I have symptoms like weight loss, fatigue, fevers, or night sweats.I have lost 10% or more of my weight in the last 6 months.
- 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.
- Group 1: Arm A (ibrutinib, obinutuzumab, venetoclax)
- Group 2: Arm B (ibrutinib, obinutuzumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
Are there specific qualifying criteria for participants of this research?
"The requirements for this study are that the potential patient has a chronic lymphocytic leukemia diagnosis and is between 18-69 years old. Up to 720 people will be accepted into the trial."
Is this a full trial or are there still opportunities for volunteers?
"Unfortunately, this particular clinical trial is no longer actively recruiting participants. The study was initially posted on 1/3/2019 but the most recent update occurred on 10/18/2022. If you are looking for other studies, there are presently 1575 clinical trials actively recruiting participants with chronic lymphocytic leukemia (cll) and 412 studies for Ibrutinib actively recruiting patients."
What is the Ibrutinib success rate in medical trials?
"Ibrutinib's safety was rated a 3 by our Power team. This is because ibrutinib has undergone Phase 3 trials, gathering data to support efficacy as well as multiple rounds of tests affirming its safety."
Is this a widespread trial in the United States?
"Salina Regional Health Center in Salina, Kansas, Franciscan Health Mooresville in Mooresville, Michigan, and Beaumont Hospital - Dearborn in Dearborn, South carolina are all enrolling patients for this trial. In addition, there are 100 other locations that are also participating."
What is the current patient sample size for this research project?
"This study is not recruiting at this moment. The trial was first posted on 1/3/2019 and updated for the last time on 10/18/2022. However, there are 1575 other trials actively recruiting patients with chronic lymphocytic leukemia (CLL) and 412 Ibrutinib trials that may be of interest."
Are individuals older than 25 years of age able to participate in this research?
"The parameters for inclusion in this particular trial are that applicants must be aged 18 to 69. There are 478 trials currently searching for patients under the age of 18 and 1670 for elderly patients."
What are the most similar Ibrutinib trials that have been completed?
"The original ibrutinib study took place in 2011 at the National Institutes of Health Clinical Center. To date, there have been a total of 308 completed clinical trials worldwide. As of right now, 412 active trials are taking place; many of these in Salina, Kansas."
For what purposes is Ibrutinib most commonly given to patients?
"Ibrutinib is often used to treat small lymphocytic lymphoma. It can also help patients with conditions like lymphoid leukemia, waldenstrom macroglobulinemia, and refractory follicular lymphoma by reducing the activity of certain enzymes."
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