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
NCT ID: NCT05753501
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
340 participants
INTERVENTIONAL
2023-06-09
2031-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation ABBV-101
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 88 month study duration.
ABBV-101
Oral:Tablet
Dose Expansion ABBV-101 R/R CLL/SLL
Participants with R/R chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 88 month study duration.
ABBV-101
Oral:Tablet
Dose Expansion ABBV-101 R/R non-GCB DLBCL
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 88 month study duration.
ABBV-101
Oral:Tablet
Interventions
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ABBV-101
Oral:Tablet
Eligibility Criteria
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Inclusion Criteria
* 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)
1. For Dose Escalation (Part 1) - BTKi/BTKd-naïve CLL/SLL backfill only: Participants with a documented diagnosis of CLL/SLL who have received at least one prior systemic therapy that cannot be a BTK inhibitor or degrader, and, with the exception of BTK pathway agents, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), and have measurable disease requiring treatment.
2. For Dose Escalation (Part 1) - BTKi/BTKd-naïve CLL/SLL backfill only: Participants with a documented diagnosis of CLL/SLL who have received one prior systemic therapy with a BTKi and BCL-2i combination regimen, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), and have measurable disease requiring treatment.
* For Dose Expansion (Part 2) CLL/SLL only: Participants with a documented diagnosis of CLL/SLL who have received at least one prior systemic therapy.
* For Dose Expansion (Part 2) DLBCL only: Participants have received at least two prior systemic therapies, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), have measurable disease requiring treatment, and have a documented diagnosis of CAR-T/HCT R/R or ineligible non-GCB DLBCL in their third line or later treatment 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.
Exclusion Criteria
* Known active central nervous system (CNS) disease, or primary CNS lymphoma. Participants with prior CNS disease that have been effectively treated may be eligible.
* Uncontrolled active systemic infection requiring systemic treatment that is ongoing or was completed \<= 14 days before the first dose of study drug, or active cytomegalovirus infection.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Hôpital 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
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2023-503594-38-00
Identifier Type: OTHER
Identifier Source: secondary_id
M23-647
Identifier Type: -
Identifier Source: org_study_id
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