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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
Condition: Hematologic Cancer · Sponsor: AbbVie
About this study
Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) non-Hodgkin's lymphomas: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed. ABBV-101 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-101. Dose expansion part 2A will follow to further determine the safety and change in disease activity in participants with first line treatment (1L\[non-US only\]), second line or later of treatment (2L)+ CLL/SLL or third line or later of treatment (3L+) non-GCB DLBCL receiving ABBV-101 alone. Dose expansion Part 2B (non-US only) will follow to determine the safety and change in disease activity in participants with 1L or 2L+ CLL/SLL receiving ABBV-101 in combination with oral venetoclax. Approximately 390 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide. In the dose escalation phase of …
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (51)
| Arizona Oncology - Tucson - Wilmot Road /ID# 252351 | Tucson, Arizona, United States | — |
| UC Irvine Medical Center /ID# 263020 | Orange, California, United States | — |
| Stanford University - Palo Alto /ID# 249683 | Palo Alto, California, United States | — |
| Rocky Mountain Cancer Centers - Lone Tree /ID# 252237 | Lone Tree, Colorado, United States | — |
| Northwestern University Feinberg School of Medicine /ID# 249347 | Chicago, Illinois, United States | — |
| Beth Israel Deaconess Medical Center /ID# 249302 | Boston, Massachusetts, United States | — |
| Rutgers Cancer Institute of New Jersey /ID# 249323 | New Brunswick, New Jersey, United States | — |
| New York Oncology Hematology - Albany Cancer Center /ID# 252240 | Albany, New York, United States | — |
| Northwell Health - Monter Cancer Center /ID# 250422 | Lake Success, New York, United States | — |
| University of Rochester Medical Center /ID# 249324 | Rochester, New York, United States | — |
| UC Health - Cincinnati /ID# 249299 | Cincinnati, Ohio, United States | — |
| Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309 | Eugene, Oregon, United States | — |
+ 39 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05753501