Pirtobrutinib vs BR for Leukemia

(BRUIN CLL-313 Trial)

Recruiting at 156 trial locations

Overseen By Patient Advocacy

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Loxo Oncology, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 years

250 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares a new drug, Pirtobrutinib, with an existing treatment, BR, in patients with CLL/SLL who have not been treated before. Pirtobrutinib works by blocking a protein that helps cancer cells grow, while BR damages cancer cells and helps the immune system destroy them.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for untreated patients with CLL/SLL who need therapy. They must have a certain level of blood cells and organ function, no severe allergies to the drugs being tested, no active hepatitis B/C or HIV, and not be on other cancer treatments or recent live vaccines.

Inclusion Criteria

I have been diagnosed with CLL/SLL and need treatment.

Platelets ≥75 x 10⁹/L (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 g/dL, and absolute neutrophil count ≥0.75 x 10⁹/L

My organs are working well.

Exclusion Criteria

My cancer has a 17p deletion.

I have active hepatitis B or C.

I do not have any ongoing serious infections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Pirtobrutinib or Bendamustine plus Rituximab

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

• Bendamustine
• Pirtobrutinib
• Rituximab

Trial Overview The study compares Pirtobrutinib (LOXO-305) against Bendamustine plus Rituximab in treating CLL/SLL. Participants will receive one of these treatments randomly and their health outcomes will be monitored for up to five years.

Participant Groups

Group I: Arm A (Pirtobrutinib) Experimental Treatment 1 Intervention

Pirtobrutinib administered orally

Group II: Arm B (BR) Active Control 2 Interventions

Bendamustine plus rituximab administered intravenously (IV)

Bendamustine is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Treanda for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Approved in European Union as Ribomustin for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma
• Multiple myeloma

Approved in Canada as Levact for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Approved in Japan as Bendamustine hydrochloride for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Who Is Running the Clinical Trial?

Loxo Oncology, Inc.

Lead Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University