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New treatment option for Hematologic Malignancies
Official title A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies
ClinicalTrials.gov ID: NCT03557619
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hematologic malignancies.
Also referred to as ABT-199, GDC-0199.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- evidence of transformation of the lymphoma immediately prior to study entry.
- Evidence of central nervous system involvement by lymphoma.
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
- Lebanon, New Hampshire, United States
- Canton, Ohio, United States
- East Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States; Lebanon, New Hampshire, United States; Canton, Ohio, United States; East Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.