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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

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