Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies

Launched by ABBVIE · Feb 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called ABBV-101 to see how safe it is and how well it works for adults with certain types of blood cancers, specifically relapsed or refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). The trial involves two main phases: one where participants will receive increasing doses of the drug to find out the highest dose that can be safely given, and another where participants will take the determined safe dose to monitor changes in their disease. About 128 adults with specific types of NHL will take part in this study at various locations around the world.

To be eligible for this trial, participants must have been diagnosed with certain B-cell malignancies and should have a life expectancy of at least 12 weeks. They need to be generally healthy, with specific blood and organ function levels. During the trial, participants will visit a hospital or clinic regularly for check-ups, blood tests, and to report any side effects they experience. It’s important to note that this study may involve more frequent treatments and visits compared to standard care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * For Dose Escalation (Part 1) only: Participants with documented diagnosis for one of the following 3L+ B-cell malignancies, from one of the following WHO-defined histologies (Swerdlow et al 2016):
• • Chronic lymphocytic leukemia (CLL)
• • Small lymphocytic lymphoma (SLL)
• • Chimeric antigen receptor T-cells (CAR-T)/hematopoietic cell transplant (HCT) relapsed/refractory (R/R) or ineligible diffuse large b-cell lymphoma (DLBCL) from the following histologies: DLBCL not otherwise specified (NOS) (germinal center B cell \[GCB\] and non-GCB DLBCL), T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, anaplastic lymphoma kinase positive (ALK+) large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS.
• • Mantle cell lymphoma (MCL)
• • Follicular lymphoma \[FL\] (grades 1-3b)
• • Marginal zone lymphoma \[MZL\] (splenic, extranodal, and nodal)
• • Waldenström macroglobulinemia (WM)
• • Transformed indolent non-Hodgkin's lymphoma (iNHL)
• • For Dose Expansion (Part 2) only: Participants with documented diagnosis of CLL who are 3L+ including those with Bruton's tyrosine kinase (BTK) mutations or CAR-T/HCT R/R or ineligible non-GCB DLBCL who are 3L+ with histology based on criteria established by the World Health Organization (WHO).
• • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2. For EU only: Participant has an ECOG PS of 0 or 1.
• • Participant has a life expectancy \>= 12 weeks.
• • Prior Bruton's tyrosine kinase inhibitor (BTKi) is allowed.
• • Adequate hematologic, renal, and hepatic function per the protocol.
• • Participants with prior central nervous system (CNS) disease that have been effectively treated may be eligible.
• Exclusion Criteria:
• • Previously treated with a Bruton's tyrosine kinase (BTK) degrader.
• • Known active CNS disease, or primary CNS lymphoma.
• • Uncontrolled active systemic infection, or active cytomegalovirus infection, known history of human immunodeficiency virus (HIV), active hepatitis B or C infection or less than 12 weeks since achieving undetectable viral load in cases of prior active hepatitis C.