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)

Status: Active_not_recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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 40 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
City of Hope /ID# 253904
Duarte
City of Hope Orange County Lennar Foundation Cancer Center /ID# 267158
Irvine
Montana
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 264622
Billings
North Carolina
Atrium Health /ID# 265136
Charlotte
Duke Cancer Center /ID# 258707
Durham
Texas
MD Anderson Cancer Center /ID# 253713
Houston
Other Locations
Australia
Austin Health /ID# 256776
Heidelberg
Royal Perth Hospital /ID# 256464
Perth
Gold coast University Hospital /ID# 255785
Southport
Royal Prince Alfred Hospital /ID# 263129
Sydney
Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 263433
Berlin
Universitaetsklinikum Halle (Saale) /ID# 263299
Halle
Universitaetsklinikum Hamburg-Eppendorf /ID# 263730
Hamburg
Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 263150
Kiel
Universitaetsklinikum Ulm /ID# 263148
Ulm
Israel
Hadassah Medical Center-Hebrew University /ID# 254721
Jerusalem
The Chaim Sheba Medical Center /ID# 254383
Ramat Gan
Yitzhak Shamir Medical Center /ID# 257626
Ẕerifin
Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 263065
Bologna
IRCCS Ospedale San Raffaele /ID# 263064
Milan
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 263062
Perugia
Time Frame
Start Date: 2025-01-27
Completion Date: 2029-07
Participants
Target number of participants: 4
Treatments
Experimental: Part A: Cohort 1.1 ABBV-453 Dose A
Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose A is achieved, during the 5 year study duration.
Experimental: Part A: Cohort 1.2 ABBV-453 Dose B
Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose B is achieved, during the 5 year study duration.
Experimental: Part A: Cohort 1.3 ABBV-453 Dose C
Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose C is achieved, during the 5 year study duration.
Experimental: Part A: Cohort 1.4 ABBV-453 Dose D
Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose D is achieved, during the 5 year study duration.
Experimental: Part A: Cohort 1.5 ABBV-453 Dose E
Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose E is achieved, during the 5 year study duration.
Experimental: Part B: Cohort 2.1 ABBV-453 Dose E
Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose E is achieved, during the 5 year study duration.
Experimental: Part B: Cohort 2.2 ABBV-453 Dose E
Participants will no participate in the debulking period and receive escalating doses of ABBV-453, until the dose E is achieved, during the 5 year study duration.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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