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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
Weight loss greater than or equal to 10% within the previous 6 months
Age greater than or equal to 18 years
Must not have
Female patients who are currently pregnant or nursing
Concomitant systemic cancer directed therapy (e.g. immunotherapy, chemotherapy, radiotherapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks.
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I have lost 10% or more of my weight in the last 6 months.
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I am 18 years old or older.
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My bone marrow is failing and getting worse.
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My spleen is significantly enlarged or getting worse.
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I have had a fever over 100.5 F for 2 weeks or more without signs of infection.
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I have had night sweats for over a month without being sick.
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I am able to care for myself and perform daily activities.
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I have been tested for allopurinol hypersensitivity.
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My condition is officially diagnosed as CLL/SLL.
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I have been tested for G6PD to see if I can receive rasburicase.
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My lymph nodes are significantly enlarged or worsening.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently pregnant or nursing.
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I am currently receiving treatment for cancer.
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I am not taking strong CYP3A4 inhibitor medications.
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My condition has transformed into a more aggressive form known as Richter's.
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I have uncontrolled autoimmune blood disorders.
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I do not have any ongoing infections that aren’t being treated.
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I have never been treated with BCL-2 inhibitors.
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I have another cancer that is getting worse or needs treatment.
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My condition significantly impacts my stomach or intestine's ability to function or absorb nutrients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the rate of clonal shift during the ramp-up phase of venetoclax

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,922 Previous Clinical Trials
47,760,671 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
~1 spots leftby Dec 2024
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