Back to search results

Venetoclax and Birth Control in Hematologic Malignancies

This study is looking at how a drug called venetoclax affects birth control pills (ethinyl estradiol and levonorgestrel) in women with certain blood cancers (hematologic malignancies). Specifically, it's for women aged 18 and older who have relapsed or refractory non-Hodgkin's lymphoma, including types like DLBCL or follicular lymphoma. The study aims to understand how venetoclax changes the levels of birth control in your body. This helps researchers understand if venetoclax might make birth control less effective. The study plans to enroll 12 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 12 female participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main measurements for drug levels will be taken for up to approximately 59 days after the initial study drug dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03557619

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

Recruiting
PHASE1Ages 18+InterventionalBasic science
AbbVie
~12 participants
Updated 2024-08-29 on ClinicalTrials.gov
What's tested:Venetoclaxethinyl estradiol/levonorgestrel

At a glance

Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tmax of Venetoclax
Measured over Up to approximately 59 days after initial study drug dose
+8 more outcomes measured

Conditions

Hematologic Malignancies

Explore related trials

Diffuse Large B-Cell LymphomaFollicular LymphomaHematologic NeoplasmLymphoplasmacytic LymphomaMantle Cell LymphomaMarginal Zone LymphomaT-cell Prolymphocytic LymphomaWaldenstrom Macroglobulinemia

Where it's being run

4 sites across 4 states
Michigan1
New Hampshire1
Ohio1
Victoria1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Tmax of VenetoclaxUp to approximately 59 days after initial study drug dose

    Time to maximum plasma concentration (Tmax) of Venetoclax.

  • Tmax of (ethinyl estradiol) EE/LevonorgestrelUp to approximately 59 days after initial study drug dose

    Time to maximum plasma concentration (Tmax) of EE/Levonorgestrel

  • Cmax of VenetoclaxUp to approximately 59 days after initial study drug dose

    Maximum plasma concentration (Cmax) of Venetoclax

  • Cmax of EE/LevonorgestrelUp to approximately 59 days after initial study drug dose

    Maximum plasma concentration (Cmax) of EE/Levonorgestrel

  • t1/2 of VenetoclaxUp to approximately 59 days after initial study drug dose

    Terminal phase elimination half-life (t1/2) of Venetoclax.

  • t1/2 of EE/LevonorgestrelUp to approximately 59 days after initial study drug dose

    Terminal phase elimination half-life (t1/2) of EE/Levonorgestrel

  • AUCt of VenetoclaxUp to approximately 59 days after initial study drug dose

    Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of Venetoclax

  • AUCt of EE/LevonorgestrelUp to approximately 59 days after initial study drug dose

    Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of EE/Levonorgestrel

  • AUCinf of EE/LevonorgestrelUp to approximately 59 days after initial study drug dose

    AUC from time 0 extrapolated to infinite time (AUCinf) of EE/Levonorgestrel.