Daratumumab + Ibrutinib for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Sikander Ailawadhi, M.D. - Doctors and ...

Overseen bySikander Ailawadhi

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well daratumumab and ibrutinib work in treating patients with chronic lymphocytic leukemia that has come back (relapsed) or has not responded to previous treatment (refractory). Daratumumab is a monoclonal antibody which works with the body's immune system to destroy cancer cells. 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 compared to ibrutinib alone.

Eligibility Criteria

This trial is for adults with chronic lymphocytic leukemia (CLL) that has returned or didn't respond to treatment. They must have been on ibrutinib previously, have measurable disease, and be in decent physical condition. Participants need normal blood counts and liver function, not be pregnant or nursing, use effective birth control, and can't have severe lung conditions or other serious health issues.

Inclusion Criteria

I was previously treated with ibrutinib and stopped, except due to severe side effects, but can safely take it again.

Absolute neutrophil count >= 1000/mm^3 (obtained =< 14 days prior to registration)

I have been treated with ibrutinib.

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Exclusion Criteria

I am of childbearing age and not using birth control.

I have not had major surgery in the last 4 weeks.

I have had moderate to severe asthma in the last 2 years or currently have uncontrolled asthma.

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Treatment Details

Interventions

Daratumumab (Monoclonal Antibodies)
Ibrutinib (Kinase Inhibitor)

Trial OverviewThe DIRECT Study is testing the combination of daratumumab (a monoclonal antibody) with ibrutinib (an enzyme blocker) against CLL that's relapsed or refractory. The goal is to see if this combo works better than just using ibrutinib alone for these patients.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (daratumumab, ibrutinib)Experimental Treatment2 Interventions

Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and then on day 1 of subsequent cycles. Beginning in cycle 2, patients also receive ibrutinib PO QD on days 1-28. Cycles 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