RECRUITING

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Description

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
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Related Conditions:

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Study Overview

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Study Details

Study overview

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Condition
Chronic Lymphocytic Leukemia
Intervention / Treatment

-

Contacts and Locations

Chandler

Ironwood Cancer & Research Centers, Chandler, Arizona, United States, 85224

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Irvine

City of Hope National Medical Center, Irvine, California, United States, 92618

Palo Alto

Palo Alto Medical Foundation Research Institute (PAMFRI), Palo Alto, California, United States, 94304

Palo Alto

Stanford Cancer Center, Palo Alto, California, United States, 94304

Aurora

Rocky Mountain Cancer Center, Aurora, Colorado, United States, 80012

Miami

University of Miami Hospital and Clinics, Sylvester Cancer Center, Miami, Florida, United States, 33136

Newnan

City of Hope National Medical Center, Atlanta Cancer Center, Newnan, Georgia, United States, 30265

Waukee

Mission Cancer + Blood, Waukee, Iowa, United States, 50263

Edgewood

Saint Elizabeth Medical Center Edgewood, Edgewood, Kentucky, United States, 41017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
  • * Part 1: Have received prior CLL/SLL treatment
  • * Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
  • * Have received a covalent BTK inhibitor
  • * Part 2: Have received no prior treatment for CLL/SLL
  • * Part 1 - Known 17p deletion status (positive or negative)
  • * Part 2 - Must have 17p deletion (positive)
  • * Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
  • * Capable of swallowing oral study medication.
  • * Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.
  • * Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
  • * Have a history of greater than or equal to (\>=) Grade 3 bleeding due to treatment with a BTK inhibitor
  • * Have known or suspected Richter's transformation
  • * Have known or suspected history of central nervous system involvement by CLL/SLL
  • * Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:
  • * nonmelanoma skin cancer or lentigo malignant melanoma
  • * cervical carcinoma in situ
  • * localized prostate cancer undergoing active surveillance, and
  • * localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Loxo Oncology, Inc.,

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2028-12