Intermittent Duvelisib for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byAlexey V Danilov

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well duvelisib on an intermittent (irregular) dosing schedule works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving duvelisib on an intermittent schedule may result in similar effectiveness with less amount of severe side effects.

Eligibility Criteria

This trial is for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who've had at least one prior treatment and need more because their disease has progressed or hasn't improved. They must be able to take pills, have decent organ function, and not be pregnant or breastfeeding. People can't join if they've recently used certain drugs, have uncontrolled other diseases, are on high-dose steroids, or have a history of severe heart problems.

Inclusion Criteria

Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than 2.5 x institutional ULN (prior to starting study drug)

My blood platelet count is at least 30,000 and my neutrophil count is at least 500, without recent transfusions.

My kidneys are functioning well enough for treatment.

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Exclusion Criteria

I haven't taken specific cancer treatments like antibodies, radio-toxins, or targeted therapy recently.

I haven't had a stroke, heart attack, severe chest pain, or serious heart rhythm problems needing treatment or a pacemaker in the last 6 months.

I have a history of HIV or active hepatitis B or C.

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Treatment Details

Interventions

Duvelisib (PI3K Inhibitor)

Trial OverviewThe trial is testing the effectiveness of Duvelisib given intermittently in patients with specific types of blood cancer. Researchers want to see if taking this drug irregularly might control the cancer while causing fewer serious side effects compared to regular dosing schedules.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (duvelisib)Experimental Treatment1 Intervention

INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Duvelisib is already approved in United States for the following indications:

🇺🇸 Approved in United States as Copiktra for: