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

Study Identifier
M16-185
CT.gov Identifier
NCT03557619
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Blood Cancer - Other
    • Study Drug
  • Venetoclax
  • ethinyl estradiol/levonorgestrel
    • Phase
    Phase 1
    Sex
    Female
    Age
    18+ years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Duplicate_Henry Ford Health System /ID# 209090
    Detroit, Michigan, United States, 48202
    Status
    Completed
    Location
    Dartmouth-Hitchcock Medical Center /ID# 169097
    Lebanon, New Hampshire, United States, 03756
    Status
    Completed
    Location
    Gabrail Cancer Center Research /ID# 207039
    Canton, Ohio, United States, 44718
    Status
    Completed
    Location
    Peter MacCallum Cancer Centre-East Melbourne /ID# 225247
    East Melbourne, Victoria, Australia, 3002
    Status
    Recruiting