Actively Recruiting
A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies
Led by AbbVie · Updated on 2024-08-29
12
Participants Needed
4
Research Sites
346 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A study to assess the effect of multiple doses of venetoclax on the pharmacokinetics of ethinyl estradiol and levonorgestrel in female participants with different hematological malignancies. Upon completion of this study, participants receiving clinical benefit in the opinion of the investigator and without any clinically significant evidence of disease progression with no access to venetoclax (not approved for the treated indication) may continue receiving venetoclax at the discretion of the investigator in a separate extension study.
CONDITIONS
Official Title
A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must have relapsed or refractory non-Hodgkin's lymphoma (NHL).
- Participant must have histologically documented diagnosis of one of the following NHL subtypes: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytic lymphoma (LPL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), T-cell prolymphocytic lymphoma (T-PLL), Waldenström's macroglobulinemia (WM)
- Has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to two.
- Must have adequate bone marrow, coagulation, renal and hepatic function as described in the protocol.
- A female of non-childbearing potential as described in the protocol.
You will not qualify if you...
- History of currently active, clinically significant cardiovascular disease.
- If the participant has had prior stem cell transplantation, it must have been more than 100 days prior to start of study drug, with no graft versus host disease, and no immunosuppression therapy.
- Evidence of transformation of the lymphoma immediately prior to study entry.
- Evidence of central nervous system involvement by lymphoma.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Duplicate_Henry Ford Health System /ID# 209090
Detroit, Michigan, United States, 48202
Completed
2
Dartmouth-Hitchcock Medical Center /ID# 169097
Lebanon, New Hampshire, United States, 03756
Completed
3
Gabrail Cancer Center Research /ID# 207039
Canton, Ohio, United States, 44718
Completed
4
Peter MacCallum Cancer Centre-East Melbourne /ID# 225247
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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