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
Hematologic Cancer
About this trial
This is an interventional treatment trial for Hematologic Cancer focused on measuring 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), Mantle cell lymphoma (MCL), Follicular lymphoma (FL), Marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), Transformed Indolent non-Hodgkin's lymphoma (INHL), Hematologic Cancer, ABBV-101
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. 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.
Sites / Locations
- Arizona Oncology Associates, PC-HOPE/ID# 252351Recruiting
- Rocky Mountain Cancer Centers /ID# 252237
- Rocky Mountain Cancer Centers/ID# 252237Recruiting
- New York Oncology Hematology - Albany Cancer Center /ID# 252240Recruiting
- Northwell Health - Monter Cancer Center /ID# 250422
- University of Rochester Cancer Center /ID# 249324
- Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield/ID# 249309Recruiting
- University of Pennsylvania /ID# 250341
- MD Anderson Cancer Center /ID# 249293
- The Chaim Sheba Medical Center /ID# 251122Recruiting
- Hadassah Medical Center-Hebrew University /ID# 251123Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Dose Escalation ABBV-101
Dose Expansion ABBV-101 R/R Chronic Lymphocytic Lymphoma (CLL)
Dose Expansion ABBV-101 R/R non-GCB DLBCL
Participants with relapsed or refractory (R/R) Non-Hodgkin's lymphoma (NHL) will receive escalating doses of ABBV-101, until the maximum administered dose (MAD)/Maximum tolerated dose (MTD) is determined, as part of the approximately 60 month study duration.
Participants with R/R CLL will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 60 month study duration.
Participants with R/R non-germinal center B cell (GCB) diffuse large B-cell lymphoma (DLBCL) will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 60 month study duration.