← Back to Search

Hormone Therapy

Venetoclax for Blood Cancers

Phase 1

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 59 days after initial study drug dose

Awards & highlights

Study Summary

This trial is studying how well venetoclax works in female patients with different types of blood cancer. Patients who benefit from the treatment and don't show disease progression may continue receiving venetoclax in an extension study.

Who is the study for?

This trial is for women with certain blood cancers like non-Hodgkin's lymphoma who have tried other treatments without success. They should be relatively active (ECOG score ≤2) and have good organ function. Women must not be able to bear children, haven't had a stem cell transplant in the last 100 days, no brain involvement by lymphoma, no serious heart disease or recent transformation of their cancer.Check my eligibility

What is being tested?

The study tests how multiple doses of Venetoclax affect the levels of birth control hormones ethinyl estradiol and levonorgestrel in women with various blood cancers. Participants benefiting from Venetoclax may continue treatment under an extension study after this one ends.See study design

What are the potential side effects?

Venetoclax can cause side effects such as nausea, diarrhea, low white blood cell counts increasing infection risk, fatigue, coughing, and potential liver problems. The impact on birth control hormone levels will also be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My non-Hodgkin's lymphoma has returned or is not responding to treatment.

Select...

I have been diagnosed with a specific type of non-Hodgkin lymphoma.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I cannot become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 59 days after initial study drug dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 59 days after initial study drug dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 59 days after initial study drug dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUCinf of EE/Levonorgestrel

AUCt of EE/Levonorgestrel

AUCt of Venetoclax

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ethinyl estradiol/Levonorgestrel and VenetoclaxExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

0 / 4Eligibility criteria met