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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

No Placebo-Only Group

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

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

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2380

Ibrutinib

2014

Completed Phase 4

~2060