238 Participants Needed

LOXO-305 for Chronic Lymphocytic Leukemia

(BRUIN CLL-321 Trial)

Recruiting at 268 trial locations
PA
SK
Overseen BySeo-Hyun Kim
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Loxo Oncology, Inc.
Must be taking: BTK inhibitors
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 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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are currently on strong CYP3A4 inhibitors or inducers, or if you require therapeutic anticoagulation with warfarin or another Vitamin K antagonist.

What evidence supports the effectiveness of the drug LOXO-305 for treating chronic lymphocytic leukemia?

Idelalisib, a component of the treatment, has shown excellent activity in chronic lymphocytic leukemia, especially in patients with certain genetic mutations. Additionally, Rituximab, when combined with standard chemotherapy, improves response rates and may prolong survival in patients with this condition.12345

Who Is on the Research Team?

MH

Marisa Hill, MD

Principal Investigator

Loxo Oncology, Inc.

Are You a Good Fit for This Trial?

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
See 6 more

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
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either LOXO-305 or investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab. Treatment continues until disease progression, discontinuation, or unacceptable toxicity.

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term if the disease does not progress

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Bendamustine
  • Idelalisib
  • LOXO-305
  • Rituximab
Trial Overview The 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A - PirtobrutinibExperimental Treatment1 Intervention
Group II: Arm B - Idelalisib plus Rituximab or Bendamustine plus RituximabActive Control3 Interventions

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

Published Research Related to This Trial

Recent advancements in treatment options for chronic lymphocytic leukemia (CLL) include novel targeted therapies like obinutuzumab and ofatumomab, which are effective and well-tolerated, especially for elderly patients or those with other health issues.
Ibrutinib and idelalisib show excellent efficacy in CLL, particularly for patients with 17p deletions, while the newly FDA-approved venetoclax offers promising results for those with relapsed or refractory disease.
Expanding the armamentarium for chronic lymphocytic leukemia: A review of novel agents in the management of chronic lymphocytic leukemia.Marini, BL., Samanas, L., Perissinotti, AJ.[2021]

Citations

Expanding the armamentarium for chronic lymphocytic leukemia: A review of novel agents in the management of chronic lymphocytic leukemia. [2021]
Practical approach to management of chronic lymphocytic leukemia. [2020]
Monoclonal antibody therapy of chronic lymphocytic leukaemia. [2010]
Chronic Lymphocytic Leukemia: Diagnosis and Treatment. [2019]
State-of-the-art treatment of chronic lymphocytic leukemia. [2019]
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