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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).

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

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

Primary outcome measures

Number of Participants With Adverse Events

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

Hypokalaemia

11%

Blood creatinine increased

11%

Neutrophil count decreased

11%

Pneumonia pseudomonal

11%

Rhinovirus infection

11%

White blood cell count decreased

11%

Dermatitis

11%

Pneumonia

11%

Abdominal pain

11%

Anaemia

11%

Sepsis

11%

Gastroenteritis

11%

SARS-CoV-2 test positive

11%

Electrocardiogram QT prolonged

11%

Febrile neutropenia

11%

COVID-19

11%

Supraventricular tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

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

~1990

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

962 Previous Clinical Trials

502,948 Total Patients Enrolled

AbbVie Inc.Study DirectorAbbVie

264 Previous Clinical Trials

101,392 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

400 Previous Clinical Trials

147,522 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many hospitals is this research project being carried out?

"There are currently 14 centres recruiting patients for this study. For example, Dartmouth-Hitchcock Med Ctr /ID# 210555 in Lebanon, University of Michigan Health Systems /ID# 231132 in Ann Arbor, and Duplicate_Gabrail Cancer Center Research /ID# 212061 in Canton."

Answered by AI

How many guinea pigs are participating in this trial?

"This study has completed recruitment for clinical trial candidates. The listing was first posted on September 6th, 2019 and was last updated on September 12th, 2020. There are presently 3334 clinical trials actively recruiting patients with malignancies and 226 trials for Venetoclax actively recruiting participants."

Answered by AI

What other sorts of research has been conducted on Venetoclax in the past?

"Venetoclax was first studied in 2014 at a well-known cancer research centre. In the 6 years since, there have been 50 completed clinical trials and presently there are 226 active clinical trials. A large portion of these are based in Lebanon, New hampshire."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

2019. "An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03844048.

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