LOXO-305 for Chronic Lymphocytic Leukemia
(BRUIN CLL-321 Trial)

Recruiting in Palo Alto (17 mi)

+268 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Loxo Oncology, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

Eligibility Criteria

This trial is for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have had previous treatment including a BTK inhibitor. They should be in fairly good health, with specific blood counts and organ function levels meeting the study's criteria. People with certain heart diseases, active infections like hepatitis or HIV, recent live vaccinations, or known allergies to the drugs being tested cannot join.

Inclusion Criteria

I can perform daily activities with little to no assistance.

AST and ALT ≤ 3.0 x upper limit of normal (ULN)

Total bilirubin ≤ 1.5 x ULN

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Exclusion Criteria

I have an active, uncontrolled immune system disorder affecting my blood cells.

I have a serious heart condition.

Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305. For patients planned to receive idelalisib, known hypersensitivity, including anaphylaxis, to any component or excipient of idelalisib. For patients planned to receive bendamustine, known hypersensitivity, including anaphylaxis, to any component or excipient of bendamustine

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Treatment Details

Interventions

Bendamustine (Alkylating Agent)
Idelalisib (PI3K Inhibitor)
LOXO-305 (BTK Inhibitor)
Rituximab (Monoclonal Antibody)

Trial OverviewThe study compares LOXO-305 against two other treatments: Idelalisib plus Rituximab or Bendamustine plus Rituximab. Patients will receive one of these treatments based on random assignment and could participate for up to four years if their disease doesn't worsen.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A - PirtobrutinibExperimental Treatment1 Intervention

Participants received 200 milligrams (mg) of pirtobrutinib administered orally once daily (QD) on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.

Group II: Arm B - Idelalisib plus Rituximab or Bendamustine plus RituximabActive Control3 Interventions

Participants received either 150 mg of idelalisib administered twice-daily (BID) orally on Days 1 through 28 of a 28-day cycle in combination with 375 milligram per square meter (mg/m\^2) of rituximab by intravenous (IV) infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 every 2 weeks (Q2W) and 3 IV infusions of rituximab 500 mg/m\^2 every 4 weeks (Q4W) or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.