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Monoclonal Antibodies
Daratumumab + Ibrutinib for Chronic Lymphocytic Leukemia
Phase 1
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 2 years
Awards & highlights
Summary
This trial tests the side effects and effectiveness of two drugs, daratumumab and ibrutinib, for treating patients with chronic lymphocytic leukemia.
Who is the study for?
This trial is for adults with symptomatic chronic lymphocytic leukemia (CLL) who need treatment and haven't had chemotherapy, immunotherapy, or targeted therapy before. Participants must have certain blood counts, no history of severe allergic reactions to monoclonal antibodies, no active infections like hepatitis B/C or HIV, and not be pregnant or breastfeeding. They should also not have any serious heart conditions or other illnesses that could interfere with the study.
What is being tested?
The trial is testing the combination of daratumumab (a monoclonal antibody) and ibrutinib (an enzyme blocker) to see if they are more effective in treating CLL compared to current treatments. The study will monitor how these drugs affect cancer cell growth and spread by analyzing biomarkers in the lab.
What are the potential side effects?
Potential side effects include infusion reactions from daratumumab such as fever and chills; bleeding problems; high blood pressure; fatigue; diarrhea; muscle spasms from ibrutinib. There may also be risks associated with liver function changes due to both medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Secondary study objectives
Duration of response (DOR)
Overall survival
Overall survival (CR + CRi + partial response [PR])
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (daratumumab, ibrutinib)Experimental Treatment4 Interventions
Patients receive daratumumab IV on days 1, 8, 15, and 22 of courses 1-2, days 1 and 15 of courses 3-6, and day 1 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Beginning course 2, patients also receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~2000
Ibrutinib
2014
Completed Phase 4
~2020
Find a Location
Who is running the clinical trial?
Jennifer WoyachLead Sponsor
3 Previous Clinical Trials
86 Total Patients Enrolled
Jennifer Woyach, MDPrincipal Investigator - Ohio State University Comprehensive Cancer Center
OSU Harding Hospital, Ohio State University Hospital - Wexner Medical Center, Richard M. Ross Heart Hospital
Ohio State University College Of Medicine (Medical School)
Oh State University Hospital (Residency)
4 Previous Clinical Trials
138 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced any of these symptoms for a certain period of time: losing more than 10% of your weight without trying, feeling very tired and unable to do normal activities, having a fever of 100.5 degrees Fahrenheit or higher for two weeks or more without an infection, or experiencing night sweats for more than a month without an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (daratumumab, 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.
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