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

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Hematologic Malignancies

Treatments: Drug: Venetoclax; Drug: ethinyl estradiol/levonorgestrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03557619

M16-185

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Ethinyl estradiol/Levonorgestrel and Venetoclax

Experimental group

Description:

Ethinyl estradiol/levonorgestrel is administered on Period 1 Day 1 and then again on Period 3 Day 1. Venetoclax is administered on Period 2 Day 1 and then daily thereafter.

Treatment:

Drug: ethinyl estradiol/levonorgestrel

Drug: Venetoclax