Non Hodgkin Lymphoma Clinical Trial

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

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: 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 in 28-day cycles, until the MAD/MTD is determined. In the dose expansion phase of the study participants receive oral ABBV-101 in 28-day cycles.

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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

128

Study ID:

NCT05753501

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 17 Locations for this study

See Locations Near You

Arizona Oncology Associates, PC-HOPE /ID# 252351
Tempe Arizona, 85284, United States
Rocky Mountain Cancer Centers /ID# 252237
Lone Tree Colorado, 80124, United States
Rutgers Cancer Institute of New Jersey /ID# 249323
New Brunswick New Jersey, 08901, United States
New York Oncology Hematology - Albany Cancer Center /ID# 252240
Albany New York, 12206, United States
Northwell Health - Monter Cancer Center /ID# 250422
Lake Success New York, 11042, United States
University of Rochester Medical Center /ID# 249324
Rochester New York, 14642, United States
Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309
Eugene Oregon, 97401, United States
University of Pennsylvania /ID# 250341
Philadelphia Pennsylvania, 19104, United States
MD Anderson Cancer Center /ID# 249293
Houston Texas, 77030, United States
Assaf Harofeh Medical Center /ID# 254566
Zerifin HaMerkaz, 70300, Israel
The Chaim Sheba Medical Center /ID# 251122
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 259608
Tel Aviv Tel-Aviv, 64239, Israel
Hadassah Medical Center-Hebrew University /ID# 251123
Jerusalem Yerushalayim, 91120, Israel
National Cancer Center Hospital East /ID# 250684
Kashiwa-shi Chiba, 277-8, Japan
Kyoto University Hospital /ID# 261837
Kyoto-shi Kyoto, 606-8, Japan
National Cancer Center Hospital /ID# 250680
Chuo-ku Tokyo, 104-0, Japan
The Cancer Institute Hospital Of JFCR /ID# 260375
Koto-ku Tokyo, 135-8, Japan

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

128

Study ID:

NCT05753501

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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