Assessing how ABBV-453 works in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma
A Phase 1 Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-453 in Adult Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
This study is testing a new drug called ABBV-453 to see if it can help adults with relapsed or hard-to-treat chronic lymphocytic leukemia or small lymphocytic lymphoma feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | obinutuzumab |
| Locations | 21 sites (Duarte, California and 20 other locations) |
| Trial ID | NCT06291220 on ClinicalTrials.gov |
What this trial studies
This study evaluates the investigational drug ABBV-453 in adult participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It consists of two parts: the first part involves administering escalating doses of ABBV-453 alongside obinutuzumab during a debulking period, while the second part continues with the maximum dose established in part A. The study aims to assess the drug's pharmacokinetics, adverse events, and changes in disease activity among approximately 80 participants across 40 sites worldwide.
Who should consider this trial
Good fit: Ideal candidates are adults with relapsed or refractory CLL/SLL who have received at least two prior systemic therapies and have no available therapies that provide clinical benefit.
Not a fit: Patients who are BCL-2 inhibitor refractory or have received a BCL-2 inhibitor within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with relapsed or refractory CLL/SLL.
How similar studies have performed: Other studies have shown promise with similar investigational approaches, but the specific use of ABBV-453 in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that has received at least 2 prior systemic therapies and have no available (or established) therapies known to provide clinical benefit and to which the participant would consent to receiving. * Laboratory values meeting those listed in the protocol. Exclusion Criteria: * QT interval corrected for heart rate (QTc) using Fridericia's correction of \> 470 msec (females) or \> 450 msec (males), Grade 3 arrythmia, and/or other clinically significant cardiac abnormalities. * Known to be B-cell leukemia/lymphoma 2 inhibitor (BCL-2i) refractory or has received a BCL-2i-containing regimen within (6 months) of starting study drug (e.g., venetoclax, lisaftoclax, BGV-11417). * Has active human immunodeficiency virus (HIV) infection. HIV testing is not required unless required locally. * Recent history (within 6 months) of: * Congestive heart failure (defined as New York Heart Association, Class 2 or higher). * Ischemic cardiovascular event. * Cardiac arrhythmia requiring pharmacological or surgical intervention. * Pericardial effusion. * Pericarditis. * Consumes known moderate or strong inhibitors of cytochrome P450 3A isoform subfamily (CYP3A) within 14 day or 5 half-lives of the drug (whichever is shorter) before the first dose of ABBV-453.
Where this trial is running
Duarte, California and 20 other locations
- City of Hope /ID# 253904 — Duarte, California, United States (Completed)
- City of Hope Orange County Lennar Foundation Cancer Center /ID# 267158 — Irvine, California, United States (Completed)
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 264622 — Billings, Montana, United States (Completed)
- Atrium Health /ID# 265136 — Charlotte, North Carolina, United States (Recruiting)
- Duke Cancer Center /ID# 258707 — Durham, North Carolina, United States (Recruiting)
- MD Anderson Cancer Center /ID# 253713 — Houston, Texas, United States (Recruiting)
- Royal Prince Alfred Hospital /ID# 263129 — Sydney, New South Wales, Australia (Completed)
- Gold coast University Hospital /ID# 255785 — SouthPort, Queensland, Australia (Recruiting)
- Austin Health /ID# 256776 — Heidelberg, Victoria, Australia (Recruiting)
- Royal Perth Hospital /ID# 256464 — Perth, Western Australia, Australia (Recruiting)
- Universitaetsklinikum Ulm /ID# 263148 — Ulm, Baden-Wuerttemberg, Germany (Completed)
- Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 263150 — Kiel, Schleswig-Holstein, Germany (Completed)
- Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 263433 — Berlin, Germany (Completed)
- Universitaetsklinikum Halle (Saale) /ID# 263299 — Halle (Saale), Germany (Recruiting)
- Universitaetsklinikum Hamburg-Eppendorf /ID# 263730 — Hamburg, Germany (Recruiting)
- Yitzhak Shamir Medical Center /ID# 257626 — Zerifin, HaMerkaz, Israel (Recruiting)
- The Chaim Sheba Medical Center /ID# 254383 — Ramat Gan, Tel-Aviv, Israel (Completed)
- Hadassah Medical Center-Hebrew University /ID# 254721 — Jerusalem, Yerushalayim, Israel (Completed)
- IRCCS Ospedale San Raffaele /ID# 263064 — Milan, Milano, Italy (Recruiting)
- IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 263065 — Bologna, Italy (Recruiting)
- Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 263062 — Perugia, Italy (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.