Daratumumab + Ibrutinib for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byJennifer Woyach, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Jennifer Woyach

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase Ib trials studies the side effects of daratumumab and ibrutinib and how well they work in treating patients with symptomatic chronic lymphocytic leukemia. Monoclonal antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving daratumumab and ibrutinib may work better in treating patients with chronic lymphocytic leukemia.

Eligibility Criteria

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.

Inclusion Criteria

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (unless due to liver involvement)

Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during and after the study; for females, these restrictions apply for 1 month after the last dose of study drug; for males, these restrictions apply for 3 months after the last dose of study drug

Positive hepatitis serology:

See 27 more

Exclusion Criteria

Patients who have had chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 28 days prior to entering the study or those who have not recovered from adverse events due to agents administered more than 28 days earlier; steroids for control of disease related symptoms are permitted

History of stroke or intracranial hemorrhage within 6 months prior to randomization

Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon); patients may be eligible if able to be taken off warfarin and started on an alternative anticoagulant

See 14 more

Treatment Details

Interventions

Daratumumab (Monoclonal Antibodies)
Ibrutinib (Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.

Daratumumab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Darzalex for:

Relapsed and refractory multiple myeloma
Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone

🇺🇸 Approved in United States as Darzalex for:

Multiple myeloma in patients who have received at least three prior therapies
Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone