Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets

Launched by ABBVIE · Nov 14, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a new oral medication called ABBV-525 for adults with certain types of B-cell cancers, such as diffuse large B-cell lymphoma and chronic lymphocytic leukemia. The study aims to find out how well the drug works, how it is absorbed in the body, and whether it causes any side effects. About 100 adult participants will take part in the trial, which involves different stages where some will receive increasing doses of the medication, while others will receive a specific dose to see how well it works.

To be eligible for this trial, participants must have been diagnosed with specific types of B-cell malignancies that have not responded to previous treatments. They should have a good performance status and be expected to live for at least 12 more weeks. Throughout the study, participants will attend regular hospital visits for assessments, blood tests, and scans. It’s important to note that this trial may require more frequent medical care than standard treatment. If you or a loved one is considering participation, it’s a chance to help advance treatment options for B-cell cancers while contributing to medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one of the following third line or later of treatment (3L)+ mature B-cell malignancies, from the World Health Organization (WHO)-defined histologies as defined in the protocol.
• • Dose Optimization (Part 2) Only: Participants with documented diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with histology based on WHO criteria, with measurable disease requiring treatment as defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
• • Dose Expansion (Part 3) Only: Participants with documented diagnosis of one of the 3L+ mature B-cell malignancies based on WHO criteria listed in the protocol, with measurable disease requiring treatment.
• • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2.
• • Participant has a life expectancy \>= 12 weeks.
• • Adequate hematological and hepatic function as defined in the protocol.
• • Must have archival or freshly collected tumor tissue for correlative studies before study enrollment.
• • Participants with prior central nervous system (CNS) disease that has been effectively treated may be eligible.
• • Participants with resolved coronavirus disease 2019 (COVID-19) infection are eligible.
• Exclusion Criteria:
• • Known active CNS disease, or primary CNS lymphoma.
• • Known bleeding disorders.
• • Known history of stroke or intracranial hemorrhage within 12 months prior to first dose of study treatment.
• • Uncontrolled active systemic infection, or active cytomegalovirus infection.
• • Active and/or chronic hepatitis B or C infection and/or the criteria listed in the protocol.
• • Known history of human immunodeficiency virus (HIV).
• • Known active COVID-19 infection. Participant must not have signs/symptoms associated with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection during screening. If participant has signs/symptoms suggestive of COVID-19 infection, the participant must have a negative molecular (e.g., polymerase chain reaction) test or 3 negative antigen test results at least 24 hours apart.