Status:
TERMINATED
Study to Evaluate Adverse Events, Change in Disease Activity, Movement of Oral ABBV-623 and ABBV-992 Tablets in the Body of Adult Participants With B-cell Cancers
Lead Sponsor:
AbbVie
Conditions:
B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
B-cell cancer is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The main objective of this study is to evaluate the safety and effica...
Eligibility Criteria
Inclusion
- Participants must have documented diagnosis for one of the following B-cell malignancies: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Waldenström's macroglobulinemia (WM), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL), with measurable disease requiring treatment.
- Participants have relapsed or refractory to at least 2 prior systemic therapies.
- Combination Dose Expansion Only: Participants with documented diagnosis of CLL/SLL with measurable disease requiring treatment per by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- CLL/SLL, MCL, WM, MZL only: Prior Bruton's tyrosine kinase inhibitor (BTKi) exposure will be allowed if participant did not progress on active treatment and there is no evidence of resistance mutations.
- Renal, liver and hematological function lab values as determined in the protocol.
- For participants with prior BTK inhibitor exposure, no evidence of mutations which confer resistance to covalent BTK inhibitors.
Exclusion
- Participants with indolent forms of non-Hodgkin lymphoma (NHL) that require immediate cytoreduction.
- Participants with prior B-cell lymphoma 2 (BCL2) inhibitor (BCL2i) exposure (except for participants in the ABBV-992 monotherapy cohort).
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04804254
Start Date
April 27 2021
End Date
January 11 2023
Last Update
February 3 2023
Active Locations (5)
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1
The Chaim Sheba Medical Center /ID# 226754
Ramat Gan, Tel Aviv, Israel, 5265601
2
Tel Aviv Sourasky Medical Center /ID# 226755
Tel Aviv, Tel Aviv, Israel, 6423906
3
Hospital del Centro Comprensivo de Cancer de la UPR /ID# 225646
San Juan, Puerto Rico, 00927
4
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 226087
Ankara, Turkey (Türkiye), 06200