250 Participants Needed

Pirtobrutinib vs BR for Leukemia

(BRUIN CLL-313 Trial)

Recruiting at 156 trial locations
PA
Overseen ByPatient Advocacy
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

C1

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

Are You a Good Fit for This Trial?

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.
See 2 more

Exclusion Criteria

My cancer has a 17p deletion.
I have active hepatitis B or C.
I do not have any ongoing serious infections.
See 12 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (Pirtobrutinib)Experimental Treatment1 Intervention
Pirtobrutinib administered orally
Group II: Arm B (BR)Active Control2 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

Find a Clinic Near You

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 profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

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