RecruitingPhase 1NCT03557619

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

A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies


Sponsor

AbbVie

Enrollment

12 participants

Start Date

Jul 30, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study checks whether a blood cancer drug called venetoclax affects how the body processes hormones found in some birth control pills — specifically ethinyl estradiol and levonorgestrel — in women being treated for a type of blood cancer called non-Hodgkin's lymphoma. **You may be eligible if...** - You are a female patient with non-Hodgkin's lymphoma that has come back or stopped responding to treatment - Your specific lymphoma type is one of: DLBCL, follicular lymphoma, lymphoplasmacytic lymphoma, mantle cell lymphoma, marginal zone lymphoma, T-cell prolymphocytic lymphoma, or Waldenström's macroglobulinemia - Your performance status (ability to carry out daily activities) is rated 2 or lower on the standard medical scale - Your bone marrow, kidney, and liver are functioning adequately - You are post-menopausal or have had a procedure that prevents pregnancy **You may NOT be eligible if...** - You have significant active heart disease - You are of childbearing potential (able to become pregnant) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

tablet; oral

DRUGethinyl estradiol/levonorgestrel

tablet; oral


Locations(4)

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

Peter MacCallum Cancer Centre-East Melbourne /ID# 225247

East Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT03557619


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