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Ibrutinib + Rituximab for Chronic Lymphocytic Leukemia
Study Summary
This trial is studying ibrutinib and rituximab compared to fludarabine phosphate, cyclophosphamide, and rituximab to see which works better in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic 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 • 201 Patients • NCT03053440Trial Design
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- I need certain medications or treatments.I have a specific condition affecting my digestive system.I have liver problems right now.I have been diagnosed with CLL or SLL.I have a confirmed diagnosis of small lymphocytic lymphoma or CLL.I meet the criteria for needing treatment.I have a bleeding disorder or hemophilia.I am experiencing symptoms related to my disease.I do not have recent heart issues, infections, strokes, active hepatitis, or abnormal lab results.
- Group 1: Arm A (ibrutinib, rituximab)
- Group 2: Arm B (rituximab, fludarabine phosphate, cyclophosphamide)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are we looking for more participants for this experiment?
"From what is available on clinicaltrials.gov, it seems as if this study has stopped looking for patients to participate. The original posting was on February 20th, 2014 with the most recent edit being on September 23rd, 2022. Even though this specific trial is no longer running, there are 4483 other trials that are still trying to recruit patients."
Why is Ibrutinib prescribed?
"Ibrutinib is a medication that, while typically used to treat lung cancer, can also be used for b-cell lymphomas, polyangium, and multiple sclerosis."
What are the aims of this research?
"The primary outcome of this study, which will be evaluated over a Baseline to 12 months after beginning therapy time frame is to Progression free survival (PFS). Secondary outcomes include Change in FACT-Leu TOI score, Overall survival (OS), and Impact of chronic lymphocytic leukemia (CLL) on QOL."
What is the FDA's position on ibrutinib?
"Ibrutinib has been evaluated for safety in multiple Phase 3 trials, meaning that there is both efficacy and safety data available. Our team rates it as a 3 on our 1 to 3 scale."
Is Ibrutinib a common medication in research trials?
"Ibrutinib is being studied in 1314 different clinical trials at the moment. Of those, 239 are in Phase 3. Although a majority of the trials for Ibrutinib are taking place in Philadelphia, Pennsylvania, there are 40806 locations running studies for this treatment across the globe."
Does this experiment have an age limit of 85 years or younger?
"As this study's eligibility requirements indicate, the minimum age for participants is 18 while the maximum is 70."
Can you tell me how many different research centers are participating in this project?
"There are 100 available for this trial. They are located at The Don and Sybil Harrington Cancer Center in Amarillo, Duly Health and Care Joliet in Joliet, New Ulm Medical Center in New Ulm, and many other places."
How many people are currently taking part in this experiment?
"Unfortunately, this trial is not looking for new patients at the moment. Although, it's important to note that the study was last updated on September 23rd, 2022. If you're interested in other anemia trials or Ibrutinib trials, there are 3169 and 1314 studies recruiting respectively."
May I apply to be a participant in this experiment?
"519 anemic patients between the ages of 18 and 70 who meet the following additional criteria are eligible for enrollment in this study: The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation [CD]19, CD20 [typically dim expression], or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc), Fevers > 100.5 Fahrenheit (F) for 2 weeks without evidence of infection, Symptomatic or progressive lymphadenopathy, splenomegaly, or hepatomegaly, Weight loss >="
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