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

• Status: Recruiting
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Levonorgestrel; Polyestradiol phosphate; Venetoclax

Criteria

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.