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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

Study Purpose

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: third line or later of treatment (3L) + 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 CLL or non-GCB DLBCL. Approximately 128 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 60 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101, as part of the approximately 60 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - For Dose Escalation (Part 1) only: Participants with documented diagnosis for one of the following 3L+ B-cell malignancies, from one of the following WHO-defined histologies (Swerdlow et al 2016): - 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) - For Dose Expansion (Part 2) only: Participants with documented diagnosis of CLL who are 3L+ including those with Bruton's tyrosine kinase (BTK) mutations or CAR-T/HCT R/R or ineligible non-GCB DLBCL who are 3L+ 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.
  • - 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.
  • - Participants with prior central nervous system (CNS) disease that have been effectively treated may be eligible.

Exclusion Criteria:

  • - Previously treated with a Bruton's tyrosine kinase (BTK) degrader.
  • - Known active CNS disease, or primary CNS lymphoma.
  • - Uncontrolled active systemic infection, or active cytomegalovirus infection, known history of human immunodeficiency virus (HIV), active hepatitis B or C infection.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05753501
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 ABBVIE INC.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Israel, Japan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Hematologic Cancer
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: 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 60 month study duration.

Experimental: Dose Expansion ABBV-101 R/R Chronic Lymphocytic Lymphoma (CLL)

Participants with R/R CLL will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 60 month study duration.

Experimental: 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 60 month study duration.

Interventions

Drug: - ABBV-101

Oral:Tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tempe, Arizona

Status

Recruiting

Address

Arizona Oncology Associates, PC-HOPE /ID# 252351

Tempe, Arizona, 85284-1812

Palo Alto, California

Status

Recruiting

Address

Stanford Cancer Center - Palo Alto /ID# 249683

Palo Alto, California, 94304-2205

Lone Tree, Colorado

Status

Recruiting

Address

Rocky Mountain Cancer Centers /ID# 252237

Lone Tree, Colorado, 80124

New Brunswick, New Jersey

Status

Recruiting

Address

Rutgers Cancer Institute of New Jersey /ID# 249323

New Brunswick, New Jersey, 08901

Albany, New York

Status

Recruiting

Address

New York Oncology Hematology - Albany Cancer Center /ID# 252240

Albany, New York, 12206-5013

Lake Success, New York

Status

Recruiting

Address

Northwell Health - Monter Cancer Center /ID# 250422

Lake Success, New York, 11042

Rochester, New York

Status

Recruiting

Address

University of Rochester Medical Center /ID# 249324

Rochester, New York, 14642-0001

Eugene, Oregon

Status

Recruiting

Address

Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309

Eugene, Oregon, 97401-6036

University of Pennsylvania /ID# 250341, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania /ID# 250341

Philadelphia, Pennsylvania, 19104

MD Anderson Cancer Center /ID# 249293, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center /ID# 249293

Houston, Texas, 77030

International Sites

Zerifin, HaMerkaz, Israel

Status

Recruiting

Address

Yitzhak Shamir Medical Center /ID# 254566

Zerifin, HaMerkaz, 70300

Ramat Gan, Tel-Aviv, Israel

Status

Recruiting

Address

The Chaim Sheba Medical Center /ID# 251122

Ramat Gan, Tel-Aviv, 5265601

Tel Aviv, Tel-Aviv, Israel

Status

Recruiting

Address

Tel Aviv Sourasky Medical Center /ID# 259608

Tel Aviv, Tel-Aviv, 6423906

Jerusalem, Yerushalayim, Israel

Status

Recruiting

Address

Hadassah Medical Center-Hebrew University /ID# 251123

Jerusalem, Yerushalayim, 91120

Kashiwa-shi, Chiba, Japan

Status

Recruiting

Address

National Cancer Center Hospital East /ID# 250684

Kashiwa-shi, Chiba, 277-8577

Kyoto University Hospital /ID# 261837, Kyoto-shi, Kyoto, Japan

Status

Recruiting

Address

Kyoto University Hospital /ID# 261837

Kyoto-shi, Kyoto, 606-8507

Chuo-ku, Tokyo, Japan

Status

Recruiting

Address

National Cancer Center Hospital /ID# 250680

Chuo-ku, Tokyo, 104-0045

Koto, Tokyo, Japan

Status

Recruiting

Address

The Cancer Institute Hospital Of JFCR /ID# 260375

Koto, Tokyo, 135-8550

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