NCT03557619 A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies
| NCT ID | NCT03557619 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | AbbVie |
| Condition | Hematologic Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2019-07-30 |
| Primary Completion | 2026-03-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2019-07-30 with a primary completion date of 2026-03-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
ABBVIE INC.
STUDY DIRECTOR
AbbVie
Frequently Asked Questions
Who can join the NCT03557619 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Hematologic Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03557619 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03557619 currently recruiting?
Yes, NCT03557619 is actively recruiting participants. Contact the research team at abbvieclinicaltrials@abbvie.com for enrollment information.
Where is the NCT03557619 trial being conducted?
This trial is being conducted at Detroit, United States, Lebanon, United States, Canton, United States, East Melbourne, Australia.
Who is sponsoring the NCT03557619 clinical trial?
NCT03557619 is sponsored by AbbVie. The principal investigator is ABBVIE INC. at AbbVie. The trial plans to enroll 12 participants.