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Trial Title:
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)
NCT ID:
NCT06291220
Condition:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Obinutuzumab
Conditions: Keywords:
Chronic Lymphocytic Leukemia: Small Lymphocytic Lymphoma
SLL
CLL
ABBV-453
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Obinutuzumab
Description:
Intravenous Infusion
Arm group label:
Part A: Cohort 1.1 ABBV-453 Dose A
Arm group label:
Part A: Cohort 1.2 ABBV-453 Dose B
Arm group label:
Part A: Cohort 1.3 ABBV-453 Dose C
Arm group label:
Part A: Cohort 1.4 ABBV-453 Dose D
Arm group label:
Part A: Cohort 1.5 ABBV-453 Dose E
Arm group label:
Part B: Cohort 2.1 ABBV-453 Dose E
Intervention type:
Drug
Intervention name:
ABBV-453
Description:
Oral; Tablet
Arm group label:
Part A: Cohort 1.1 ABBV-453 Dose A
Arm group label:
Part A: Cohort 1.2 ABBV-453 Dose B
Arm group label:
Part A: Cohort 1.3 ABBV-453 Dose C
Arm group label:
Part A: Cohort 1.4 ABBV-453 Dose D
Arm group label:
Part A: Cohort 1.5 ABBV-453 Dose E
Arm group label:
Part B: Cohort 2.1 ABBV-453 Dose E
Arm group label:
Part B: Cohort 2.2 ABBV-453 Dose E
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. There are 2 parts
to this study. In part A participants will be placed 1 of 5 cohorts with a specific
target dose for each cohort and receive obinutuzumab during the debulking period followed
escalating doses of ABBV-453, until the appropriate target dose is achieved. In part B
participants will be placed in 2 cohorts and receive up to the maximum dose in part A,
with cohort 2.1 including a debulking period (obinutuzumab) as in part A. Approximately
80 adult participants with previously R/R CLL/SLL will be enrolled in the study in
approximately 28 sites across the world.
Participants in part A will placed into 1 of 5 cohorts with a specific target dose for
each cohort and 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. Participants in part B will be place in one of 2 cohorts. Participants in
cohort 2.1 will receive IV obinutuzumab as part of the debulking period, followed by
escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved.
Participants in cohort 2.2 will receive no treatment during the the debulking period,
followed by escalating doses of oral ABBV-453 until the maximum target dose from part A
is achieved. The estimated study duration is 5 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/ small lymphocytic
lymphoma (SLL) that has received at least 2 prior anti-cancer systemic therapies and
does not have another therapy that is more appropriate at the judgement of the
Investigator.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope /ID# 253904
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope Orange County Lennar Foundation Cancer Center /ID# 267158
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Facility:
Name:
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 264622
Address:
City:
Billings
Zip:
59102
Country:
United States
Status:
Recruiting
Facility:
Name:
Royal Prince Alfred Hospital /ID# 263129
Address:
City:
Sydney
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
Gold coast University Hospital /ID# 255785
Address:
City:
SouthPort
Zip:
4215
Country:
Australia
Status:
Recruiting
Facility:
Name:
Austin Health /ID# 256776
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Hamburg-Eppendorf /ID# 263730
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Facility:
Name:
Yitzhak Shamir Medical Center /ID# 257626
Address:
City:
Zerifin
Zip:
70300
Country:
Israel
Status:
Recruiting
Facility:
Name:
The Chaim Sheba Medical Center /ID# 254383
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center-Hebrew University /ID# 254721
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Start date:
August 9, 2024
Completion date:
July 21, 2029
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06291220
https://www.abbvieclinicaltrials.com/study/?id=M24-291