← Back to Search

BCL-2 Inhibitor

Venetoclax for Chronic Lymphocytic Leukemia

Phase 2
Recruiting
Led By Christopher MT Pleyer, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Anemia and/or thrombocytopenia
Weight loss greater than or equal to 10% within the previous 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks (primary endpoint). f/u every 6 months thereafter until disease progression.
Awards & highlights

Study Summary

This trial is studying venetoclax in people with relapsed or refractory chronic lymphocytic leukemia. Venetoclax will be given to see if it can help to control the disease.

Who is the study for?
Adults over 18 with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) who've had at least one prior therapy. Participants must have active disease, be able to take oral medication, and agree to use contraception if necessary. They can't join if they've used BCL-2 inhibitors before, have uncontrolled infections or other serious health issues, are pregnant/nursing, or have certain blood count levels.Check my eligibility
What is being tested?
The trial is testing how venetoclax affects CLL cancer cells and the immune system. It involves a ramp-up phase where doses increase weekly until the maximum tolerable dose is reached. Afterward, participants continue treatment locally but visit NIH every six months for tests like blood draws, CT scans, and bone marrow biopsies.See study design
What are the potential side effects?
Venetoclax may cause side effects such as nausea, diarrhea, low white blood cell counts increasing infection risk; anemia; fatigue; and potential liver function changes. Regular monitoring will help manage these risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have anemia or low platelet count.
Select...
I have lost 10% or more of my weight in the last 6 months.
Select...
I am 18 years old or older.
Select...
I understand this is a research study and I can give my consent.
Select...
I experience extreme tiredness that doesn't improve with rest.
Select...
My bone marrow is failing and getting worse.
Select...
My cancer doctor will continue my venetoclax treatment after the initial phase.
Select...
My spleen is significantly enlarged or getting worse.
Select...
I have had a fever over 100.5 F for 2 weeks or more without signs of infection.
Select...
I have had night sweats for over a month without being sick.
Select...
I am able to care for myself and perform daily activities.
Select...
I have been tested for allopurinol hypersensitivity.
Select...
My condition is officially diagnosed as CLL/SLL.
Select...
I have been tested for G6PD to see if I can receive rasburicase.
Select...
My lymph nodes are significantly enlarged or worsening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks (primary endpoint). f/u every 6 months thereafter until disease progression.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks (primary endpoint). f/u every 6 months thereafter until disease progression. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the rate of clonal shift during the ramp-up phase of venetoclax
Secondary outcome measures
Bone Marrow

Trial Design

1Treatment groups
Experimental Treatment
Group I: Relapsed/Refractory CLL ptsExperimental Treatment1 Intervention
Ages 18 and older

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,819 Previous Clinical Trials
47,295,682 Total Patients Enrolled
Christopher MT Pleyer, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
3 Previous Clinical Trials
694 Total Patients Enrolled

Media Library

Venetoclax (BCL-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03986034 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Relapsed/Refractory CLL pts
Chronic Lymphocytic Leukemia Clinical Trial 2023: Venetoclax Highlights & Side Effects. Trial Name: NCT03986034 — Phase 2
Venetoclax (BCL-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03986034 — Phase 2

Frequently Asked Questions

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

Can adults within a certain age range participate in this research study?

"This clinical trial is open to patients aged 18-90. There are 469 other studies available for minors and 1491 research options for senior citizens."

Answered by AI

What are the possible side effects associated with taking Venetoclax?

"While there is some evidence to support the safety of Venetoclax, it did not receive a higher score because this is only a Phase 2 trial. This means that while there are data supporting safety, there are no reports indicating its efficacy."

Answered by AI

Could you give me the screening criteria for this research project?

"Up to 55 patients, who are between 18 and 90 years old and have leukemia, will be included in this trial. To qualify for the study, participants must also suffer from fatigue, night sweats (with no evidence of infection), large nodes or clusters, progressive lymphadenopathy, weight loss of 10% or more in the last 6 months, fevers of 100.5 F or higher for 2 weeks or more (without evidence of infection), massive or progressive splenomegaly."

Answered by AI

Are people still able to join this clinical trial?

"The study is still recruiting patients, according to the information available on clinicaltrials.gov. This trial was first posted on June 26th, 2019 and was last updated on October 1st, 2022."

Answered by AI

Has Venetoclax been researched before in other clinical trials?

"As of now, there are 226 clinical trials involving During Venetoclax with 29 in Phase 3. Most investigations for During Venetoclax are happening in Boston, Massachusetts; however, there are 7269 locations running these tests."

Answered by AI

How many guinea pigs are currently testing this new medication?

"That is correct, the most recent information available on clinicaltrials.gov demonstrates that this trial is still recruiting patients. This study was first posted on June 26th, 2019 and has been updated as recently as October 1st, 2020. 55 participants are needed from 1 site to complete this research."

Answered by AI
Recent research and studies
~9 spots leftby Dec 2024