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Recruiting Phase 1 NCT03557619

A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies

Phase 1 – testing safety in a small group of people
Conditions: Hematologic Malignancies

Sponsor: AbbVie

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Locations 2
Australia (1)
Peter MacCallum Cancer Centre-East Melbourne /ID# 225247
East Melbourne , Victoria
United States (1)
Duplicate_Henry Ford Health System /ID# 209090
Detroit , Michigan
COMPLETED
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
30.07.2019
Completion date
21.03.2026
Registry ID
NCT03557619
Source
anzctr
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