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Bruton's Tyrosine Kinase (BTK) Inhibitor
Ibrutinib for High-risk CLL/SLL
Phase 2
Waitlist Available
Led By Jennifer Woyach, MD
Research Sponsored by Jennifer Woyach
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is testing ibrutinib with different vaccine therapies to see if it is a better treatment for patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma who do not have any symptoms.
Who is the study for?
This trial is for patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma who haven't had previous treatment. They should have certain genetic markers, a life expectancy over 24 months, and be in relatively good health (ECOG <=2). Participants must not show signs needing immediate CLL/SLL treatment, have other serious illnesses or infections, or be on conflicting medications.Check my eligibility
What is being tested?
The study tests if the drug Ibrutinib combined with vaccines (pneumococcal, influenza, diphtheria/tetanus/pertussis) can help treat asymptomatic high-risk CLL/SLL by enhancing the immune response to fight cancer cells. It's a phase II trial where participants are randomly assigned to receive this combination therapy.See study design
What are the potential side effects?
Ibrutinib may cause side effects like diarrhea, bleeding problems, high blood pressure, fatigue and muscle pains. Vaccines could lead to injection site reactions, fever or mild flu-like symptoms. The severity of side effects varies from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients who are alive and progression-free
Secondary outcome measures
Degree of response (CR MRD-,CR, PR, PR with lymphocytosis, and SD)
Incidence of adverse events, evaluated using the NCI CTCAE version 4.0
Proportion of patients who achieve complete response
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (sequential vaccines and ibrutinib)Experimental Treatment7 Interventions
Patients receive pneumococcal 13-valent conjugate vaccine IM on day 1 of courses 1 and 3 and trivalent influenza IM and DTaP vaccine IM on day 1 of course 2. Beginning in course 4, patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (concurrent vaccines and ibrutinib)Experimental Treatment7 Interventions
Patients receive ibrutinib PO QD on days 1-28. Patients also receive pneumococcal 13-valent conjugate vaccine IM on day 1 of courses 3 and 5 and trivalent influenza vaccine IM and DTaP vaccine IM on day 1 of course 4. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Trivalent Influenza Vaccine
2010
Completed Phase 4
~2630
Pneumococcal 13-valent Conjugate Vaccine
2019
Completed Phase 4
~4440
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Who is running the clinical trial?
Jennifer WoyachLead Sponsor
3 Previous Clinical Trials
59 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,778 Total Patients Enrolled
Jennifer Woyach, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
4 Previous Clinical Trials
111 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Arm A (concurrent vaccines and ibrutinib)
- Group 2: Arm B (sequential vaccines and ibrutinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the patient population involved in this research endeavor?
"This clinical trial is no longer recruiting participants, as it was initially posted on December 1st 2016 and last edited February 24th 2022. However, 2865 studies for Chronic lymphocytic leukemia (CLL) are currently searching for patients, and 212 pharmacology trials have open admissions."
Answered by AI
Has the Pharmacological Study been granted authorization from the FDA?
"As a second-phase clinical trial, there is only limited proof of its safety score at 2 on the scale. Unfortunately, no data exists to suggest efficacy yet."
Answered by AI
Are there currently any vacancies available for prospective participants in this research?
"At this time, no more participants are being accepted for the study which commenced on December 1st 2016. If you're looking for other clinical trials, there are currently 2865 studies actively seeking patients with chronic lymphocytic leukemia (CLL) and 212 studies that involve pharmacological research recruiting volunteers."
Answered by AI
How has Pharmacological Study been deployed to benefit patients?
"Pharmacological Study can be utilized to ameliorate the effects of poliomyelitis, diphtheria, and streptococcus pneumoniae."
Answered by AI
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