Assessing the effect of venetoclax on certain medications in women with blood cancers
A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies
This study is testing how the cancer drug venetoclax affects the way certain birth control medications work in women with blood cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 4 sites (Detroit, Michigan and 3 other locations) |
| Trial ID | NCT03557619 on ClinicalTrials.gov |
What this trial studies
This study evaluates how multiple doses of venetoclax influence the pharmacokinetics of ethinyl estradiol and levonorgestrel in female participants diagnosed with various hematological malignancies. Participants must have relapsed or refractory non-Hodgkin's lymphoma and meet specific health criteria. If participants show clinical benefit and no significant disease progression, they may continue receiving venetoclax in a separate extension study. The study aims to gather important data on drug interactions and potential treatment benefits.
Who should consider this trial
Good fit: Ideal candidates are women with relapsed or refractory non-Hodgkin's lymphoma who meet specific health criteria.
Not a fit: Patients with currently active cardiovascular diseases or those who have had recent stem cell transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatment options for women with hematological malignancies.
How similar studies have performed: While this approach is novel in assessing the interaction of venetoclax with these medications, similar studies have shown promise in understanding drug interactions in cancer treatments.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Detroit, Michigan and 3 other locations
- Duplicate_Henry Ford Health System /ID# 209090 — Detroit, Michigan, United States (Completed)
- Dartmouth-Hitchcock Medical Center /ID# 169097 — Lebanon, New Hampshire, United States (Completed)
- Gabrail Cancer Center Research /ID# 207039 — Canton, Ohio, United States (Completed)
- Peter MacCallum Cancer Centre-East Melbourne /ID# 225247 — East Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.