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Triple Drug Therapy for Chronic Lymphocytic Leukemia
Study Summary
This trial is testing a new combination of drugs to treat leukemia. The drugs are ibrutinib, fludarabine, and pembrolizumab. The trial is open to patients with leukemia who have not responded to other treatments.
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.Trial Design
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Who is running the clinical trial?
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- I have not had major surgery in the last 4 weeks.My condition meets one of the required criteria for active disease.I have not taken any excluded medications recently.I have another cancer that is getting worse or needs treatment.I am 18 years old or older.I am not pregnant, breastfeeding, and I am willing to use contraception.I do not have any ongoing serious infections or uncontrolled medical conditions.I have not had a stroke or brain bleed in the last 6 months.I have a serious illness or a condition that affects how my organs work.I am a male and unwilling to follow contraception guidelines.I have a serious liver condition right now.My organs are working well enough for the study.I have not needed treatment for an autoimmune disease in the last 2 years.I need to take blood thinners like Coumadin.I understand the study's purpose and can give informed consent.My CLL has transformed into a non-Hodgkin lymphoma.I do not have major digestive system issues or related surgeries.I am fully active or have some restrictions but can still take care of myself.I have been diagnosed with CLL or SLL.I have had lung inflammation treated with steroids.My condition is considered high-risk based on specific criteria.I have not received any live vaccines in the last 4 weeks.I have a serious heart condition that is currently affecting me.
- Group 1: Ibrutinib, Fludarabine, and Pembrolizumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- 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
What ailments commonly necessitate the use of Pembrolizumab?
"Pembrolizumab is commonly used for the treatment of unresectable melanoma and has been found to be beneficial in other cases such as microsatellite instability high, a heightened risk of recurrence, and general disease progression."
Is enrollment ongoing for this research endeavor?
"Sadly, according to clinicaltrials.gov this particular medical research is no longer recruiting individuals for the trial. It was originally posted in September of 2017 and last updated on August 2nd 2022. Fortunately there are a substantial number (2347) of other studies that are still searching for participants at the moment."
In what other research initiatives has Pembrolizumab been utilized?
"Currently, 1466 clinical trials are in progress concerning Pembrolizumab. Of these investigations, 165 are currently in phase 3. Although Houston is the main hub for this treatment's research and development, there exists 45691 different sites running related studies."
How many participants are involved in this scientific experiment?
"Unfortunately, recruitment for this trial has now closed. Initially posted on September 22nd 2017 and most recently edited on August 2nd 2022, the study is no longer enrolling participants. For alternative options, 881 trials related to weight loss are actively recruiting patients at present and there are 1466 studies involving Pembrolizumab currently accepting applications from participants."
Has the Food and Drug Administration (FDA) given their stamp of approval to Pembrolizumab?
"Pembrolizumab's safety is judged to be a 2, since it has only been tested in Phase 2 trials. There have not yet been any studies validating its efficacy."
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