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

Recruiting now · Phase 1

Conditions studied: Hematologic Malignancies

In brief

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.

Key facts

Study ID

NCT03557619

Run by

AbbVie

People needed

12

Starts

2019-07-30

Expected to finish

2026-03-21

Last updated by the study team

2024-08-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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.

Where it is running

• Peter MacCallum Cancer Centre-East Melbourne /ID# 225247 — East Melbourne, Victoria, Australia (enrolling)
• Duplicate_Henry Ford Health System /ID# 209090 — Detroit, Michigan, United States
• Dartmouth-Hitchcock Medical Center /ID# 169097 — Lebanon, New Hampshire, United States
• Gabrail Cancer Center Research /ID# 207039 — Canton, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.