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

Description

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.

Conditions

Hematologic Malignancies

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Study Overview

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Study Details

Study 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.

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

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

Condition
Hematologic Malignancies
Intervention / Treatment

-

Contacts and Locations

Detroit

Duplicate_Henry Ford Health System /ID# 209090, Detroit, Michigan, United States, 48202

Lebanon

Dartmouth-Hitchcock Medical Center /ID# 169097, Lebanon, New Hampshire, United States, 03756

Canton

Gabrail Cancer Center Research /ID# 207039, Canton, Ohio, United States, 44718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2026-03-21