Recruiting NCT07226843
A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LY4584180, Rituximab.
- Who it may be relevant to
- Registry conditions: Lymphoma, Non-Hodgkin's, Lymphoma, Diffuse Large B-Cell, Follicular Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Germany, Italy, Japan +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
NOVA-BCL6-1, A First-in-Human, Multicenter Phase 1a/1b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of LY4584180 in Adult Participants With Previously Treated Hematologic Malignancies
Overview
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
- Drug LY4584180
administered orally - Drug Rituximab
administered through IV infusion
Primary outcome measures
- Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities [Time frame: Baseline up to Day 28]
- Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Time frame: Baseline up to 3 Years]
- To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR) [Time frame: Baseline up to 3 Years]
Secondary outcome measures (2)
- Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180 [Time frame: Baseline to Day 8]
- PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180 [Time frame: Baseline to Day 8]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 21 centers
- Mayo Clinic - Scottsdale — Scottsdale
- City of Hope — Duarte
- University of California, Los Angeles (UCLA) - Medical Center — Los Angeles
- University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer — San Francisco
- Colorado Blood Cancer Institute — Denver
- University of Miami - Sylvester Cancer Center — Miami
- Florida Cancer Specialists - Sarasota — Sarasota
- Emory University Hospital — Atlanta
- … and 13 more centers
France · 5 centers
- CHU de Nantes - Hotel-Dieu — Nantes
- Institut Curie — Paris
- CHU Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie — Pessac
- HCL Centre Hospitalier Lyon Sud — Pierre-Bénite
- Oncopole Claudius Regaud — Toulouse
United Kingdom · 5 centers
- King's College Hospital — London
- The Royal Marsden NHS Foundation Trust — London
- Nottingham City Hospital — Nottingham
- Derriford Hospital — Plymouth
- University Hospital Southampton NHS Foundation Trust — Southampton
Germany · 4 centers
- Charite Universitaetsmedizin Berlin — Berlin
- Universitaetsklinikum Koeln (AoeR) — Cologne
- Universitaetsklinikum Essen — Essen
- Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet — Frankfurt am Main
Poland · 4 centers
- Pratia Onkologia Katowice — Katowice
- Pratia MCM Krakow — Krakow
- AIDPORT Sp. z o.o. — Skorzewo
- Instytut Hematologii i Transfuzjologii w Warszawie — Warsaw
Japan · 3 centers
- National Cancer Center Hospital East — Chiba
- Okayama University Hospital — Okayama
- Cancer Institute Hospital of JFCR — Tokyo
Italy · 2 centers
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola — Bologna
- Istituto Europeo di Oncologia — Milan
Spain · 2 centers
- Institut Catala d'Oncologia - L'Hospitalet — Barcelona
- South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez — Madrid
Identifiers
NCT: NCT07226843 · 27804 · J6Y-OX-JBFA · 2025-523601-16-00