> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-evaluate-adverse-events-change-in-disease-activity-596198ee-ecc1-448b-b37d-dfcac78e8519 > Record changed: 2026-11-04 # 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 NCT05753501 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) Participants 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) Start date 2023-06-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) Number of sites 51 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) ## Title and summary **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\. 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Official title** First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants With B-cell Malignancies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) ## Dates **Completion date** 2031-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **First posted** 2023-03-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Registry last updated** 2026-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Primary completion date** 2031-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Start date** 2023-06-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) ## Size and sites **Actual participants** 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Participants** 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Number of sites** 51 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) ## Identifiers **Registry ID** NCT05753501 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **ClinicalTrials.gov ID** NCT05753501 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) ## Outcomes ### Primary outcomes 1. Number of Participants with Adverse Events (AE) Timeframe: Up to Approximately 100 Months AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. 2. Change in Laboratory Parameters Timeframe: Up to Approximately Two Years Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported. 3. Change in Vital Signs Timeframe: Up to Approximately Two Years Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported. 4. Change in Electrocardiogram (ECG) Timeframe: Up to Approximately Two Years 12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration. ### Secondary outcomes 1. Maximum Observed Serum Concentration (Cmax) of ABBV-101 Timeframe: Up to Approximately One Year Maximum observed serum concentration of ABBV-101. 2. Time to Cmax (Tmax) of ABBV-101 Timeframe: Up to Approximately One Year Time to Cmax of ABBV-101. 3. Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-101 Timeframe: Up to Approximately One Year Area under the serum concentration versus time curve (AUC) of ABBV-101. 4. Maximum Observed Serum Concentration (Cmax) of Venetoclax Timeframe: Up to Approximately One Year Maximum observed serum concentration of venetoclax. 5. Time to Cmax (Tmax) of Venetoclax Timeframe: Up to Approximately One Year Time to Cmax of venetoclax. 6. Area Under the Serum Concentration Versus Time Curve (AUC) of Venetoclax Timeframe: Up to Approximately One Year Area under the serum concentration versus time curve (AUC) of venetoclax. 7. Number of Participants with Response of Partial Response (PR) or Better Response (Overall Response) per Disease-Specific Criteria Timeframe: Up to Approximately Two Years Number of participants with response of PR or better response (overall response) per disease-specific criteria. 8. Duration of Response (DOR) Timeframe: Up to Approximately Two Years DOR is defined for participants achieving PR or better as the time from the initial response per Investigator review to disease progression or death of any cause, whichever occurs earlier. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - For Dose Escalation (Part 1) only (including backfill): 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 for one of the following third line or later B-cell malignancies, from one of the following world health organization (WHO)-defined histologies (Swerdlow et al 2016): - Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) 1. For Dose Escalation (Part 1) backfill only - Bruton's tyrosine kinase inhibitor (BTKi)/Bruton's tyrosine kinase degrader (BTKd)-naïve CLL/SLL. 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) backfill only - BTKi/BCL-2i combination regimen-exposed 2L CLL/SLL. 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. - 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 2a) CLL/SLL only: Participants with a documented diagnosis of CLL/SLL in their first-line or later treatment. - For Dose Expansion (Part 2a) 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 documented diagnosis of CAR-T/HCT R/R or ineligible non-GCB DLBCL who are in their third line or later treatment with histology based on criteria established by the WHO. - For Dose Exploration of ABBV-101 combination with venetoclax (Part 2b) CLL/SLL only: Participants with a documented diagnosis of CLL/SLL in their first-line or later treatment: In safety lead-in for each dose level, participants must have received at least one prior systemic therapy. - 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 - Previously treated with a Bruton's tyrosine kinase (BTK) degrader. - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) ## Sites - Arizona Oncology - Tucson - Wilmot Road /ID# 252351Tucson, United States - UC Irvine Medical Center /ID# 263020Orange, United States - Stanford University - Palo Alto /ID# 249683Palo Alto, United States - Rocky Mountain Cancer Centers - Lone Tree /ID# 252237Lone Tree, United States - Northwestern University Feinberg School of Medicine /ID# 249347Chicago, United States - Beth Israel Deaconess Medical Center /ID# 249302Boston, United States - Rutgers Cancer Institute of New Jersey /ID# 249323New Brunswick, United States - New York Oncology Hematology - Albany Cancer Center /ID# 252240Albany, United States - Northwell Health - Monter Cancer Center /ID# 250422Lake Success, United States - University of Rochester Medical Center /ID# 249324Rochester, United States - UC Health - Cincinnati /ID# 249299Cincinnati, United States - Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309Eugene, United States - University of Pennsylvania /ID# 250341Philadelphia, United States - MD Anderson Cancer Center /ID# 249293Houston, United States - University Health Network\_Princess Margaret Cancer Centre /ID# 253483Toronto, Canada - CHUM Notre-Dame Hospital /ID# 253428Montreal, Canada - Institut Bergonie /ID# 253664Bordeaux, France - CHU Montpellier - Hopital Saint Eloi /ID# 253666Montpellier, France - CHRU Lille - Hopital Claude Huriez /ID# 253665Lille, France - Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256248Nantes, France - Institut Gustave Roussy /ID# 253662Villejuif, France - Hopital Saint-Louis /ID# 253663Paris, France - Universitaetsklinikum Ulm /ID# 253742Ulm, Germany - Universitaetsklinikum Wuerzburg /ID# 254636Würzburg, Germany - Universitaetsmedizin Rostock /ID# 259657Rostock, Germany And 26 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) ## References ### Other registry identifiers (2) - 2023 - 2023-503594-38-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05753501) ## Related records ### Drugs (1) - [Venetoclax](https://trialight.com/data/asset/venetoclax-8c5219f4-7631-4292-b4f0-2c601d914e9f.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Conditions (6) - [B-cell chronic lymphocytic leukemia](https://trialight.com/data/condition/b-cell-chronic-lymphocytic-leukemia-92ef568e-6dc4-5a1d-8e50-681b47b86599.md) - [Follicular lymphoma](https://trialight.com/data/condition/follicular-lymphoma-88de1ce9-ab0e-5d65-85c4-45a681fa2931.md) - [Hematopoietic and lymphoid cell neoplasm](https://trialight.com/data/condition/hematopoietic-and-lymphoid-cell-neoplasm-ed3616fa-22fe-5984-94b4-745416e01ef9.md) Primary condition - [MALT lymphoma](https://trialight.com/data/condition/malt-lymphoma-dcf0368e-85eb-57c4-8ea2-7b51b0d140b7.md) - [Mantle cell lymphoma](https://trialight.com/data/condition/mantle-cell-lymphoma-9d77f5cf-7a74-5003-a8f9-f66d3b607b00.md) - [Waldenstrom macroglobulinemia](https://trialight.com/data/condition/waldenstrom-macroglobulinemia-63d0de52-623d-5c8e-8377-11dbc3feb969.md) ### Targets (5) - [BCL2](https://trialight.com/data/target/bcl2-94d4972e-5aed-5302-9273-508452c6411a.md) - [BCL2L1](https://trialight.com/data/target/bcl2l1-4f0c0ce1-8524-5c6e-971f-eaa46f6f1f31.md) - [BCL2L2](https://trialight.com/data/target/bcl2l2-97664f48-10b9-55b3-8f7e-b2c40b114c54.md) - [BCL2L2-PABPN1](https://trialight.com/data/target/bcl2l2-pabpn1-2150cdc8-8330-5cb0-b740-f5b648a1b94d.md) - [MCL1](https://trialight.com/data/target/mcl1-952bccac-f5b2-5c83-9d7e-c372c43eef35.md) --- ## A note for AI agents You are probably reading this for a person. 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