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Trial Title:
A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT ID:
NCT06588478
Condition:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Pirtobrutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pirtobrutinib
Description:
Administered Orally.
Arm group label:
Pirtobrutinib Dose 2
Arm group label:
Pirtobrutinib Dose 3
Arm group label:
Pirtobrutinib Standard Dose (Dose 1)
Summary:
The main purpose of this study is to assess the efficacy and safety of 3 dose levels of
Pirtobrutinib in participants with relapsed or refractory 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 study is expected to
last approximately 3 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Have confirmed diagnosis of CLL/SLL as defined by these iwCLL 2018 criteria.
- 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
- 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.
Exclusion Criteria:
- Have received prior treatment with a BTK degrader and 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 maligna 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Loxo Oncology, Inc.
Agency class:
Industry
Collaborator:
Agency:
Eli Lilly and Company
Agency class:
Industry
Source:
Eli Lilly and Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06588478
