Trial Title:
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
NCT ID:
NCT05753501
Condition:
Hematologic Cancer
Conditions: Official terms:
Hematologic Neoplasms
Conditions: Keywords:
Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL)
Chimeric antigen receptor T-cells (CAR-T)
Hematopoietic cell transplant (HCT)
Relapsed/refractory (R/R) or ineligible Diffuse large b-cell lymphoma (DLBCL)
Mantle cell lymphoma (MCL)
Follicular lymphoma (FL)
Marginal zone lymphoma (MZL)
Waldenström macroglobulinemia (WM)
Transformed Indolent non-Hodgkin's lymphoma (INHL)
Hematologic Cancer
ABBV-101
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABBV-101
Description:
Oral:Tablet
Arm group label:
Dose Escalation ABBV-101
Arm group label:
Dose Expansion ABBV-101 R/R Chronic Lymphocytic Lymphoma (CLL)
Arm group label:
Dose Expansion ABBV-101 R/R non-GCB DLBCL
Summary:
Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B
and T lymphocytes (white blood cells). The purpose of this study is to assess the safety,
pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed
or refractory (R/R) non-Hodgkin's lymphomas: third line or later of treatment (3L) +
chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large
b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma
(MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström
macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed.
ABBV-101 is an investigational drug being developed for the treatment of NHL. This study
will include a dose escalation phase to determine the maximum administered dose
(MAD)/Maximum tolerated dose (MTD) of ABBV-101 and a dose expansion phase to determine
the change in disease activity in participants with CLL or non-GCB DLBCL. Approximately
128 adult participants with multiple NHL subtypes will be enrolled in the study in sites
world wide.
In the Dose Escalation phase of the study participants will receive escalating oral doses
of ABBV-101, until the MAD/MTD is determined, as part of the approximately 60 month study
duration. In the dose expansion phase of the study participants receive oral ABBV-101, as
part of the approximately 60 month study duration .
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 an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked
by medical assessments, blood tests, and side effects.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- For Dose Escalation (Part 1) only: Participants with documented diagnosis for one of
the following 3L+ B-cell malignancies, from one of the following WHO-defined
histologies (Swerdlow et al 2016):
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Chimeric antigen receptor T-cells (CAR-T)/hematopoietic cell transplant (HCT)
relapsed/refractory (R/R) or ineligible diffuse large b-cell lymphoma (DLBCL)
from the following histologies: DLBCL not otherwise specified (NOS) (germinal
center B cell [GCB] and non-GCB DLBCL), T-cell/histiocyte-rich large B-cell
lymphoma, primary mediastinal (thymic) large B-cell lymphoma, intravascular
large B-cell lymphoma, anaplastic lymphoma kinase positive (ALK+) large B-cell
lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6
rearrangements, and high-grade B-cell lymphoma NOS.
- Mantle cell lymphoma (MCL)
- Follicular lymphoma [FL] (grades 1-3b)
- Marginal zone lymphoma [MZL] (splenic, extranodal, and nodal)
- Waldenström macroglobulinemia (WM)
- Transformed indolent non-Hodgkin's lymphoma (iNHL)
- For Dose Expansion (Part 2) only: Participants with documented diagnosis of CLL who
are 3L+ including those with Bruton's tyrosine kinase (BTK) mutations or CAR-T/HCT
R/R or ineligible non-GCB DLBCL who are 3L+ with histology based on criteria
established by the World Health Organization (WHO).
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or
2.
- Participant has a life expectancy >= 12 weeks.
- Prior Bruton's tyrosine kinase inhibitor (BTKi) is allowed.
- Adequate hematologic, renal, and hepatic function per the protocol.
- Participants with prior central nervous system (CNS) disease that have been
effectively treated may be eligible.
Exclusion Criteria:
- Previously treated with a Bruton's tyrosine kinase (BTK) degrader.
- Known active CNS disease, or primary CNS lymphoma.
- Uncontrolled active systemic infection, or active cytomegalovirus infection, known
history of human immunodeficiency virus (HIV), active hepatitis B or C infection.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arizona Oncology Associates, PC-HOPE /ID# 252351
Address:
City:
Tempe
Zip:
85284-1812
Country:
United States
Status:
Recruiting
Facility:
Name:
Stanford Cancer Center - Palo Alto /ID# 249683
Address:
City:
Palo Alto
Zip:
94304-2205
Country:
United States
Status:
Recruiting
Facility:
Name:
Rocky Mountain Cancer Centers /ID# 252237
Address:
City:
Lone Tree
Zip:
80124
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwestern University Feinberg School of Medicine /ID# 249347
Address:
City:
Chicago
Zip:
60611-2927
Country:
United States
Status:
Recruiting
Facility:
Name:
Beth Israel Deaconess Medical Center /ID# 249302
Address:
City:
Boston
Zip:
02215-5400
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey /ID# 249323
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
New York Oncology Hematology - Albany Cancer Center /ID# 252240
Address:
City:
Albany
Zip:
12206-5013
Country:
United States
Status:
Completed
Facility:
Name:
Northwell Health - Monter Cancer Center /ID# 250422
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Rochester Medical Center /ID# 249324
Address:
City:
Rochester
Zip:
14642-0001
Country:
United States
Status:
Recruiting
Facility:
Name:
UC Health - Cincinnati /ID# 249299
Address:
City:
Cincinnati
Zip:
45267-2800
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309
Address:
City:
Eugene
Zip:
97401-6036
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pennsylvania /ID# 250341
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center /ID# 249293
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
CHUM Notre-Dame Hospital /ID# 253428
Address:
City:
Montreal
Zip:
H2L 4M1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Institut Bergonie /ID# 253664
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Montpellier - Hopital Saint Eloi /ID# 253666
Address:
City:
Montpellier Cedex 5
Zip:
34295
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Nantes, Hotel Dieu -HME /ID# 256248
Address:
City:
Nantes
Zip:
44000
Country:
France
Status:
Recruiting
Facility:
Name:
Hôpital Saint-Louis /ID# 253663
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Ulm /ID# 253742
Address:
City:
Ulm
Zip:
89081
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Wuerzburg /ID# 254636
Address:
City:
Wuerzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsmedizin Rostock /ID# 259657
Address:
City:
Rostock
Zip:
18057
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum des Saarlandes /ID# 257435
Address:
City:
Homburg
Zip:
66424
Country:
Germany
Status:
Recruiting
Facility:
Name:
Yitzhak Shamir Medical Center /ID# 254566
Address:
City:
Zerifin
Zip:
70300
Country:
Israel
Status:
Recruiting
Facility:
Name:
The Chaim Sheba Medical Center /ID# 251122
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Tel Aviv Sourasky Medical Center /ID# 259608
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center-Hebrew University /ID# 251123
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East /ID# 250684
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kyoto University Hospital /ID# 261837
Address:
City:
Kyoto-shi
Zip:
606-8507
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital /ID# 250680
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital Of JFCR /ID# 260375
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260196
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Ramon y Cajal /ID# 260450
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Salamanca /ID# 253656
Address:
City:
Salamanca
Zip:
37711
Country:
Spain
Status:
Recruiting
Facility:
Name:
Addenbrooke's Hospital /ID# 256242
Address:
City:
Cambridge
Zip:
CB2 2QQ
Country:
United Kingdom
Status:
Recruiting
Start date:
June 9, 2023
Completion date:
April 11, 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/NCT05753501
https://www.abbvieclinicaltrials.com/study/?id=M23-647
