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Ibrutinib +/− Rituximab for Chronic Lymphocytic Leukemia
Study Summary
This trial is studying ibrutinib with or without rituximab to see which is more effective in treating patients with chronic lymphocytic leukemia that has come back after treatment.
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 haven't had cancer treatments like chemotherapy or immunotherapy in the last 21 days.I haven't had major surgery or a serious injury in the last 28 days and don't expect to need major surgery during the study.I do not have an ongoing infection that isn't getting better with treatment.I do not have uncontrolled autoimmune blood disorders.I do not have severe diseases or organ problems that make treatment risky.I have not had a stroke or brain bleed in the last 6 months.I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.I agree to use effective birth control during and 30 days after the study.I haven't had cancer (except certain skin, cervix, or breast cancers) in the last 3 years.I can take care of myself and am up and about more than half of my waking hours.I am 18 or older, understand and agree to the study's consent, and can follow the study procedures.I have not had bleeding or clotting problems in the last 3 months.My kidneys work well enough, with a creatinine clearance over 30 mL/min.I am recommended for treatment based on specific leukemia guidelines.My blood tests show very low white blood cells or platelets not due to my condition.I have a serious wound or fracture that is not healing.I have not had minor surgery or needle biopsies in the last week, except for bone marrow procedures.I have not taken Coumadin in the last 7 days.I have been treated with ibrutinib or similar drugs but not with Zydelig.I have CLL/SLL/PLL, treated before or untreated with specific genetic changes.
- Group 1: Arm I (ibrutinib)
- Group 2: Arm II (ibrutinib, rituximab)
- 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
Is this research initiative currently accepting participants?
"This clinical trial is not currently open for enrollment. It was first posted on December 6th 2013 and last updated October 31st 2022, so it appears to be inactive at this time. Fortunately, there are 2439 studies actively looking for patients with relapse and 521 trials recruiting participants that use Ibrutinib as an intervention."
In what contexts is Ibrutinib customarily utilized?
"DLBCL often requires Ibrutinib for effective treatment, but this same drug is also beneficial in managing b-cell lymphomas, polyangiitis, and pemphigus vulgaris."
Have there been any other investigations involving Ibrutinib?
"Presently, there are 105 clinical trials for Ibrutinib in Phase 3 and 521 active studies worldwide. In particular, Ascoli Piceno has the highest concentration of ongoing research projects at 1835 sites."
Is Ibrutinib a proven secure option for individuals?
"Through our review, the safety of Ibrutinib was rated a 2 since Phase 2 trials have revealed it to be safe but efficacy has yet to be proven."
What is the current enrollment count for this research endeavor?
"At present, this medical trial is not enrolling patients. It was first posted on December 6th 2013 and last updated in October 2022. Nevertheless, 2439 clinical trials for relapse are actively admitting participants with ibrutinib recruiting 521 of its own volunteers."
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