A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies
- Conditions
- Hematologic Malignancies
- Interventions
- Drug: ethinyl estradiol/levonorgestrel
- Registration Number
- NCT03557619
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 12
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ethinyl estradiol/Levonorgestrel and Venetoclax ethinyl estradiol/levonorgestrel Ethinyl estradiol/levonorgestrel is administered on Period 1 Day 1 and then again on Period 3 Day 1. Venetoclax is administered on Period 2 Day 1 and then daily thereafter. Ethinyl estradiol/Levonorgestrel and Venetoclax Venetoclax Ethinyl estradiol/levonorgestrel is administered on Period 1 Day 1 and then again on Period 3 Day 1. Venetoclax is administered on Period 2 Day 1 and then daily thereafter.
- Primary Outcome Measures
Name Time Method Tmax of Venetoclax Up to approximately 59 days after initial study drug dose Time to maximum plasma concentration (Tmax) of Venetoclax.
AUCt of Venetoclax Up to approximately 59 days after initial study drug dose Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of Venetoclax
t1/2 of Venetoclax Up to approximately 59 days after initial study drug dose Terminal phase elimination half-life (t1/2) of Venetoclax.
t1/2 of EE/Levonorgestrel Up to approximately 59 days after initial study drug dose Terminal phase elimination half-life (t1/2) of EE/Levonorgestrel
Cmax of Venetoclax Up to approximately 59 days after initial study drug dose Maximum plasma concentration (Cmax) of Venetoclax
Cmax of EE/Levonorgestrel Up to approximately 59 days after initial study drug dose Maximum plasma concentration (Cmax) of EE/Levonorgestrel
AUCinf of EE/Levonorgestrel Up to approximately 59 days after initial study drug dose AUC from time 0 extrapolated to infinite time (AUCinf) of EE/Levonorgestrel.
Tmax of (ethinyl estradiol) EE/Levonorgestrel Up to approximately 59 days after initial study drug dose Time to maximum plasma concentration (Tmax) of EE/Levonorgestrel
AUCt of EE/Levonorgestrel Up to approximately 59 days after initial study drug dose Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of EE/Levonorgestrel
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Duplicate_Henry Ford Health System /ID# 209090
🇺🇸Detroit, Michigan, United States
Peter MacCallum Cancer Centre-East Melbourne /ID# 225247
🇦🇺East Melbourne, Victoria, Australia
Gabrail Cancer Center Research /ID# 207039
🇺🇸Canton, Ohio, United States
Dartmouth-Hitchcock Medical Center /ID# 169097
🇺🇸Lebanon, New Hampshire, United States