Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ethinyl estradiol/levonorgestrel | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ethinyl estradiol/Levonorgestrel and Venetoclax
- 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.
- interventionNames
- Drug: Venetoclax
- Drug: ethinyl estradiol/levonorgestrel
Primary outcomes (9)
- measure
- Tmax of Venetoclax
- timeFrame
- Up to approximately 59 days after initial study drug dose
- description
- Time to maximum plasma concentration (Tmax) of Venetoclax.
- measure
- Tmax of (ethinyl estradiol) EE/Levonorgestrel
- timeFrame
- Up to approximately 59 days after initial study drug dose
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available