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Venetoclax Extension Study for Leukemia

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has been enrolled and dosed in an ongoing venetoclax study and continues to tolerate and derive benefit from the study drug.
Female subjects must not be pregnant or breastfeeding.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will provide more safety data for people who are already taking venetoclax and benefiting from it.

Who is the study for?
This trial is for people who have been part of a venetoclax study, are still benefiting from it without major issues, and aren't pregnant or breastfeeding. Men must agree not to donate sperm during the trial.
What is being tested?
The study continues giving venetoclax to participants from previous trials to gather more information on its long-term safety and ongoing effectiveness in treating various types of blood cancers.
What are the potential side effects?
Venetoclax may cause side effects like nausea, diarrhea, low white blood cell count (increasing infection risk), fatigue, coughing, and potential respiratory complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently taking venetoclax for my condition and it's working without severe side effects.
Select...
I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Adverse Events

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Sepsis
11%
Abdominal pain
11%
Pneumonia
11%
Rhinovirus infection
11%
COVID-19
11%
Gastroenteritis
11%
Pneumonia pseudomonal
11%
Electrocardiogram QT prolonged
11%
Anaemia
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Febrile neutropenia
11%
Supraventricular tachycardia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: VenetoclaxExperimental Treatment1 Intervention
Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2200

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,020 Previous Clinical Trials
519,923 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,456 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
442 Previous Clinical Trials
160,372 Total Patients Enrolled

Media Library

Venetoclax Clinical Trial Eligibility Overview. Trial Name: NCT03844048 — Phase 3
Cancer Research Study Groups: Venetoclax
Cancer Clinical Trial 2023: Venetoclax Highlights & Side Effects. Trial Name: NCT03844048 — Phase 3
Venetoclax 2023 Treatment Timeline for Medical Study. Trial Name: NCT03844048 — Phase 3
~32 spots leftby Feb 2026
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