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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
NCT05753501 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG ABBV-101
Study Locations (20)
New York
- New York Oncology Hematology - Albany Cancer Center /ID# 252240 — Albany
- Northwell Health - Monter Cancer Center /ID# 250422 — Lake Success
- University of Rochester Medical Center /ID# 249324 — Rochester
California
- UC Irvine Medical Center /ID# 263020 — Orange
- Stanford University /ID# 249683 — Palo Alto
Arizona
- Arizona Oncology Associates, PC-HOPE /ID# 252351 — Tempe
Colorado
- Rocky Mountain Cancer Centers - Lone Tree /ID# 252237 — Lone Tree
Illinois
- Northwestern University Feinberg School of Medicine /ID# 249347 — Chicago
Massachusetts
- Beth Israel Deaconess Medical Center /ID# 249302 — Boston
New Jersey
- Rutgers Cancer Institute of New Jersey /ID# 249323 — New Brunswick
Ohio
- UC Health - Cincinnati /ID# 249299 — Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2023-06-09 |
| Est. Completion | 2031-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05753501
The ClinicalTrials.gov registry entry for NCT05753501 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hematologic Cancer appearing as the primary indexed condition, and to 1 intervention — of which ABBV-101 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05753501 reports 20 study locations spanning 17 distinct geographic areas — top geographies include New York, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05753501 about?
NCT05753501 is a clinical study titled "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". 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'...
What is the current status of trial NCT05753501?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 340 participants. The study started on 2023-06-09. Estimated completion is 2031-03.
What conditions does trial NCT05753501 study?
This clinical trial studies the following conditions: Hematologic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05753501?
The interventions under investigation include: ABBV-101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05753501?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05753501 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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