Follicular Lymphoma, Lymphoma, Diffuse Large B-Cell, Lymphoma, Non-Hodgkin's
Conditions
Brief summary
The main purpose of this study is to evaluate safety and efficacy, and measure how much LY4584180 gets into the bloodstream and how long it takes the body to eliminate it in patients with previously treated blood cancers. For each participant, the study could last about 9 months or possibly longer including screening.
Interventions
DRUGLY4584180
administered orally
DRUGRituximab
administered through IV infusion
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has been treated for the following blood cancers and has received at least 2 prior lines of systemic therapy or not eligible for available therapy: * Diffuse large B-cell lymphoma - not otherwise specified * High-grade B-cell lymphoma * Diffuse large B-cell lymphoma - transformed from indolent lymphomas * Follicular large B-cell lymphoma * Follicular lymphoma * Other non-Hodgkin lymphoma * Has measurable disease * Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy
Exclusion criteria
* Has an active second cancer * Has known central nervous system (CNS) involvement by systemic lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of active CNS disease may be eligible and enrolled if a compelling clinical rationale is provided by the Investigator and with documented Sponsor approval. * Has known Cytomegalovirus infection. Participants with negative status are eligible * Has known hepatitis B or C infection or uncontrolled HIV * Has known significant heart disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities | Baseline up to Day 28 | Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities |
| Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline up to 3 Years | Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
| To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR) | Baseline up to 3 Years | To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180 | Baseline to Day 8 | PK: Cmax of LY4584180 |
| PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180 | Baseline to Day 8 | PK: AUC versus time curve of LY4584180 |
Countries
France, Germany, Italy, Japan, Poland, Spain, United Kingdom, United States
Contacts
CONTACTTrial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed