Pirtobrutinib + VR for Chronic Lymphocytic Leukemia
(BRUIN CLL-322 Trial)

Recruiting in Palo Alto (17 mi)

+314 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?The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

Eligibility Criteria

This trial is for people with CLL/SLL who need treatment and have already tried at least one therapy. They should be in fairly good health (ECOG 0-2), have a certain level of blood cells, and their kidneys must work well enough (creatinine clearance ≥30 mL/min). People can't join if they've had certain infections, HIV, hepatitis B or C, previous venetoclax treatment, allergies to the drugs used here, recent live vaccines or stem cell transplants.

Inclusion Criteria

I have been treated with a specific cancer medication before.

Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

My organs are working well.

+3 more

Exclusion Criteria

I need blood thinners like warfarin for my condition.

My cancer has spread to my brain or spinal cord.

I have not received a live vaccine in the last 28 days.

+14 more

Participant Groups

The study tests Pirtobrutinib combined with Venetoclax and Rituximab against just Venetoclax and Rituximab in patients previously treated for CLL/SLL. The goal is to see which combination works better and is safer over up to five years.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (PVR)Experimental Treatment3 Interventions

Fixed duration pirtobrutinib in combination with venetoclax and rituximab

Group II: Arm B (VR)Active Control2 Interventions

Venetoclax with rituximab

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

🇺🇸 Approved in United States as Jaypirca for: