Study Summary
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 and a dose expansion phase to determine the change in disease activity in participants with first line treatment (1L), second line or later of treatment (2L)+ CLL/SLL or third line or later of treatment (3L) non-GCB DLBCL. Approximately 340 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 88 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101, as part of the approximately 88 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.
Want to learn more about this trial?
Request More InfoInterventions
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Arizona Oncology Associates, PC-HOPE /ID# 252351 | Tempe | Arizona | United States |
| UC Irvine Medical Center /ID# 263020 | Orange | California | United States |
| Stanford University /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 |
| University of Pennsylvania /ID# 250341 | Philadelphia | Pennsylvania | United States |
| MD Anderson Cancer Center /ID# 249293 | Houston | Texas | United States |
| University Health Network_Princess Margaret Cancer Centre /ID# 253483 | Toronto | Ontario | Canada |
| CHUM Notre-Dame Hospital /ID# 253428 | Montreal | Quebec | Canada |
| Institut Bergonie /ID# 253664 | Bordeaux | Gironde | France |
| CHU Montpellier - Hopital Saint Eloi /ID# 253666 | Montpellier | Herault | France |
| CHRU Lille - Hopital Claude Huriez /ID# 253665 | Lille | Nord | France |
| Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256248 | Nantes | Pays de la Loire Region | France |
| Institut Gustave Roussy /ID# 253662 | Villejuif | Val-de-Marne | France |
| Hopital Saint-Louis /ID# 253663 | Paris | France | |
| Universitaetsklinikum Ulm /ID# 253742 | Ulm | Baden-Wurttemberg | Germany |
| Universitaetsklinikum Wuerzburg /ID# 254636 | Würzburg | Bavaria | Germany |
| Universitaetsmedizin Rostock /ID# 259657 | Rostock | Mecklenburg-Vorpommern | Germany |
| Universitaetsklinikum des Saarlandes /ID# 257435 | Homburg | Saarland | Germany |
| 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 | Israel |
| Hadassah Medical Center-Hebrew University /ID# 251123 | Jerusalem | Jerusalem | Israel |
| The Chaim Sheba Medical Center /ID# 251122 | Ramat Gan | Tel Aviv | Israel |
| Tel Aviv Sourasky Medical Center /ID# 259608 | Tel Aviv | Tel Aviv | Israel |
| IRCCS Ospedale San Raffaele /ID# 253531 | Milan | Milano | Italy |
| ASST Grande Ospedale Metropolitano Niguarda /ID# 253532 | Milan | Milano | Italy |
| A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 253530 | Turin | Piedmont | Italy |
| ASST 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 | Japan |
| Kyoto University Hospital /ID# 261837 | Kyoto | Kyoto | Japan |
| National Cancer Center Hospital /ID# 250680 | Chuo-ku | Tokyo | Japan |
| The Cancer Institute Hospital Of JFCR /ID# 260375 | Koto-ku | Tokyo | Japan |
| Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260196 | Majadahonda | Madrid | Spain |
| Hospital Universitario Vall de Hebron /ID# 260447 | Barcelona | Spain | |
| Hospital Universitario Ramon y Cajal /ID# 260450 | Madrid | Spain | |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 253654 | Madrid | Spain | |
| Hospital Universitario HM Sanchinarro /ID# 253655 | Madrid | Spain | |
| Hospital Universitario de Salamanca /ID# 253656 | Salamanca | Spain | |
| Addenbrookes Hospital /ID# 256242 | Cambridge | Cambridgeshire | United Kingdom |
| Leicester Royal Infirmary /ID# 255171 | Leicester | England | United Kingdom |
| University College London Hospital /ID# 260202 | London | Greater London | United Kingdom |
| Kings College Hospital NHS Foundation Trust /ID# 253670 | London | Greater London | United Kingdom |