Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by AbbVie.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disabil
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 |
What the registry record for NCT06291220 still lists
NCT06291220 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (98% lower).
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 names 20 study sites across 16 states, led by 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.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
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 NCT06291220's enrollment target sits among peer trials
4 187th of 187 the lowest 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
RECRUITING · Phase 1
-
Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
RECRUITING · Phase 1
-
Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL
RECRUITING · Phase 1
-
Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
RECRUITING · Phase 1
-
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
RECRUITING · Phase 1
-
Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI