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NCT05512390 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)
A Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT05512390: Recruiting Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by AbbVie.
NCT05512390 is a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma that is actively recruiting participants, run by AbbVie. The registered enrollment target is 154 participants, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05512390, a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
Study Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), or R/R CLL. Adverse events will be assessed. ABBV-319 is an investigational drug being developed for the treatment of R/R DLBCL, R/R FL, or R/R CLL. This study will include a dose escalation phase to determine the doses of ABBV-319 that will be used in the next phase and a dose expansion phase to determine the change in disease activity in participants with R/R DLBCL, R/R FL, and R/R CLL. Approximately 154 adult participants with R/R B cell lymphomas including R/R DLBCL, R/R FL, and R/R CLL will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the Phase 2 dose is determined. In the dose expansion phase of the study participants receive intravenously infused ABBV-319 in 21-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, questionnaires and side effects.
Primary Outcome
A DLT is defined as any adverse event (AE) for which a clear alternative cause cannot be established (eg, attributed to the disease under study, another disease, or to a concomitant medication by the study investigators or medical monitor).
Conditions Studied
Interventions
- DRUG ABBV-319
Study Locations (20)
Seoul Teugbyeolsi
- Seoul National University Hospital /ID# 263945 - Seoul
- Asan Medical Center /ID# 263220 - Seoul
- Samsung Medical Center /ID# 263294 - Seoul
Texas
- Baylor Sammons Cancer Center /ID# 247715 - Dallas
- University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234 - San Antonio
Other
- Hadassah Medical Center-Hebrew University /ID# 254885 - Jerusalem
- Hospital Universitario Fundacion Jimenez Diaz /ID# 265198 - Madrid
Arizona
- University of Arizona Cancer Center - Tucson /ID# 247752 - Tucson
Florida
- Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232 - Miami
Minnesota
- Allina Health System /ID# 251782 - Minneapolis
Nebraska
- University of Nebraska Medical Center /ID# 246715 - Omaha
New York
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246 - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2023-04-26 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What NCT05512390 shows while recruiting
NCT05512390 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (15% lower).
The record links to 3 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which ABBV-319 is the first listed.
NCT05512390 names 20 study sites across 16 states, led by Seoul Teugbyeolsi, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT05512390 about?
NCT05512390 is a clinical study titled "A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)". B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose...
What is the current status of trial NCT05512390?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 154 participants. The study started on 2023-04-26. Estimated completion is 2027-02.
What conditions does trial NCT05512390 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Follicular Lymphoma.
What interventions are being tested in trial NCT05512390?
The interventions under investigation include: ABBV-319 (DRUG).
Who is sponsoring clinical trial NCT05512390?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05512390 being conducted?
This trial has 20 study locations across Arizona, Florida, Minnesota, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05512390's enrollment target sits among peer trials
154 49th of 187 higher than 138 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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