ABBV-101: Oral:Tablet
Venetoclax: Oral
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 the study participants will receive escalating oral doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 100 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101 alone or oral ABBV-101 at a dose determined in the dose escalation phase in combination with oral venetoclax, as part of the approximately 100 month study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Oncology - Tucson - Wilmot Road /ID# 252351 | Tucson | Arizona | |
| UC Irvine Medical Center /ID# 263020 | Orange | California | |
| Stanford University - Palo Alto /ID# 249683 | Palo Alto | California | |
| Rocky Mountain Cancer Centers - Lone Tree /ID# 252237 | Lone Tree | Colorado | |
| Northwestern University Feinberg School of Medicine /ID# 249347 | Chicago | Illinois | |
| Beth Israel Deaconess Medical Center /ID# 249302 | Boston | Massachusetts | |
| Rutgers Cancer Institute of New Jersey /ID# 249323 | New Brunswick | New Jersey | |
| New York Oncology Hematology - Albany Cancer Center /ID# 252240 | Albany | New York | |
| Northwell Health - Monter Cancer Center /ID# 250422 | Lake Success | New York | |
| University of Rochester Medical Center /ID# 249324 | Rochester | New York | |
| UC Health - Cincinnati /ID# 249299 | Cincinnati | Ohio | |
| Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309 | Eugene | Oregon | |
| University of Pennsylvania /ID# 250341 | Philadelphia | Pennsylvania | |
| MD Anderson Cancer Center /ID# 249293 | Houston | Texas | |
| University Health Network_Princess Margaret Cancer Centre /ID# 253483 | Toronto | Ontario | |
| CHUM Notre-Dame Hospital /ID# 253428 | Montreal | Quebec | |
| Institut Bergonie /ID# 253664 | Bordeaux | Gironde | |
| CHU Montpellier - Hopital Saint Eloi /ID# 253666 | Montpellier | Herault | |
| CHRU Lille - Hopital Claude Huriez /ID# 253665 | Lille | Nord | |
| Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256248 | Nantes | Pays de la Loire Region | |
| Institut Gustave Roussy /ID# 253662 | Villejuif | Val-de-Marne | |
| Hopital Saint-Louis /ID# 253663 | Paris | France | |
| Universitaetsklinikum Ulm /ID# 253742 | Ulm | Baden-Wurttemberg | |
| Universitaetsklinikum Wuerzburg /ID# 254636 | Würzburg | Bavaria | |
| Universitaetsmedizin Rostock /ID# 259657 | Rostock | Mecklenburg-Vorpommern | |
| Universitaetsklinikum des Saarlandes /ID# 257435 | Homburg | Saarland | |
| Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 257431 | Berlin | Germany | |
| Universitaetsklinikum Hamburg-Eppendorf /ID# 264566 | Hamburg | Germany | |
| Yitzhak Shamir Medical Center /ID# 254566 | Ẕerifin | Central District | |
| Hadassah Medical Center-Hebrew University /ID# 251123 | Jerusalem | Jerusalem | |
| The Chaim Sheba Medical Center /ID# 251122 | Ramat Gan | Tel Aviv | |
| Tel Aviv Sourasky Medical Center /ID# 259608 | Tel Aviv | Tel Aviv | |
| IRCCS Ospedale San Raffaele /ID# 253531 | Milan | Milano | |
| ASST Grande Ospedale Metropolitano Niguarda /ID# 253532 | Milan | Milano | |
| A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 253530 | Turin | Piedmont | |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII /ID# 260317 | Bergamo | Italy | |
| IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255172 | Bologna | Italy | |
| National Cancer Center Hospital East /ID# 250684 | Kashiwa-shi | Chiba | |
| Kyoto University Hospital /ID# 261837 | Kyoto | Kyoto | |
| National Cancer Center Hospital /ID# 250680 | Chuo-ku | Tokyo |
+ 11 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05753501 on ClinicalTrials.gov ↗ ← All trials in the USA