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NCT06291220 · ClinicalTrials.gov registry record · Phase 1
A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
A Phase 1 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by AbbVie.
- Active
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 20
- Study locations
NCT06291220 is a Phase 1 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 4 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT06291220, a Phase 1 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 20
- Study locations
Study Summary
Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in disease activity will be assessed. ABBV-453 is an investigational drug for the treatment of CLL and SLL. Participants will be enrolled with a specific target dose and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. Approximately 60 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 40 sites across the world. Participants will receive intravenous (IV) obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the appropriate target dose is achieved. The estimated study duration is 3 years. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG ABBV-453
Study Locations (20)
Other
- Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 263433 - Berlin
- Universitaetsklinikum Hamburg-Eppendorf /ID# 263730 - Hamburg
- IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 263065 - Bologna
California
- City of Hope /ID# 253904 - Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 267158 - Irvine
North Carolina
- Atrium Health /ID# 265136 - Charlotte
- Duplicate_Duke Cancer Center /ID# 258707 - Durham
Montana
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 264622 - Billings
Texas
- MD Anderson Cancer Center /ID# 253713 - Houston
New South Wales
- Royal Prince Alfred Hospital /ID# 263129 - Sydney
Queensland
- Gold coast University Hospital /ID# 255785 - Southport
Victoria
- Austin Health /ID# 256776 - Heidelberg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2025-01-27 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06291220
The ClinicalTrials.gov registry entry for NCT06291220 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (98% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Obinutuzumab is the first listed.
NCT06291220 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Other, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06291220 about?
NCT06291220 is a clinical study titled "A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)". Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in diseas...
What is the current status of trial NCT06291220?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2025-01-27. Estimated completion is 2027-07.
What conditions does trial NCT06291220 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT06291220?
The interventions under investigation include: Obinutuzumab (DRUG), ABBV-453 (DRUG).
Who is sponsoring clinical trial NCT06291220?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06291220 being conducted?
This trial has 20 study locations across California, Montana, North Carolina, Texas, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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