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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
Constitutional symptoms, which include any of the following: Unintentional weight loss of 10% or more within 6 months, Significant fatigue limiting activity, Fevers >= 100.5 degrees Fahrenheit (F) for 2 weeks or more without evidence of infection, Night sweats > 1 month without evidence of infection
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response (CR) + complete response with incomplete marrow recovery (CRi) defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria
Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Secondary outcome measures
Duration of response (DOR)
Overall survival
Overall survival (CR + CRi + partial response [PR])
+1 more

Trial 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
~1860
Ibrutinib
2014
Completed Phase 3
~1880

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

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03447808 — Phase 1
Chronic Lymphocytic Leukemia Research Study Groups: Treatment (daratumumab, ibrutinib)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT03447808 — Phase 1
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03447808 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participants in this trial?

"This clinical trial is no longer recruiting participants, with the last edit being on August 22nd 2022. Currently, 1522 studies related to Chronic lymphocytic leukemia (CLL) are actively enrolling patients and 291 Pharmacological Study trials are searching for enrollees."

Answered by AI

Are there any precedent investigations on Pharmacological Study?

"Currently, 291 clinical trials for Pharmacological Study are ongoing with 49 Phase 3 studies. While Karlsruhe and Quebec have a noteworthy number of these medical experiments taking place, there are 12,739 locations running some type of pharmacological trial."

Answered by AI

What is the primary purpose of this experimentation?

"This research endeavour will span up to two years, with the purpose of assessing National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0-defined adverse events. Secondary outcomes include overall survival (summarized by Kaplan-Meier method), overall survival in complete remissions and partial responses accompanied by a 95% confidence interval, as well as progression-free survival summarized likewise by Kaplan-Meier methodology."

Answered by AI

What is the aggregate figure of participants in this research project?

"Unfortunately, recruiting for this trial has now closed. It was initially posted on the 16th of August 2018 and last updated on the 22nd of August 2022. If you are hopeful to find other medical studies relevant to your condition, there are 1522 trials searching for participants with chronic lymphocytic leukemia (CLL) and 291 Pharmacological Studies actively enrolling patients."

Answered by AI

What conditions tend to be treated with Pharmacological Study?

"Pharmacological Study is a popular treatment for biological response modifiers, but it has been used to address an array of other medical issues including refractory multiple myeloma, relapsed or refractory multiple myeloma, and cell transplants."

Answered by AI

To what degree can participating in a Pharmacological Study be hazardous to someone's health?

"The safety of this pharmacological study has been evaluated at 1 on the scale due to Phase 1 testing, which implies that only preliminary data is available regarding efficacy and security."

Answered by AI
~2 spots leftby Mar 2025