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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

Hematologic Malignancies

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

Inclusion Criteria5

  • 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 Criteria4

  • 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.

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

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NCT03557619

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