Early Clonal Dynamics During Venetoclax Treatment for Relapsed or Refractory Chronic Lymphocytic … (NCT03986034) | Clinical Trial Compass
RecruitingPhase 2
Early Clonal Dynamics During Venetoclax Treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
United States75 participantsStarted 2019-06-26
Plain-language summary
Background:
The drug venetoclax treats chronic lymphocytic leukemia (CLL). Researchers want to find better treatments for CLL. To do that, they need to learn how the drug affects CLL cancer cells and the immune system.
Objective:
To learn about genetic changes that happen during treatment of CLL with venetoclax.
Eligibility:
Adults ages 18 and older with relapsed or refractory CLL after at least 1 prior therapy
Design:
Participants will be screened under a separate protocol.
In Phase 1, participants will get venetoclax free of charge through the NIH. Venetoclax is started at a low dose. The dose will be increased every week until participants reach their maximum tolerable dose. This usually take about 5 weeks. Participants will visit the NIH at least once per week. Visits will be about 4 hours. They may have to stay in the hospital to be observed.
In Phase 2, participants will continue to get the drug through their local cancer doctor and their health insurance. Patients will also visit the NIH every 6 months, or if their disease progresses.
At the NIH participants will have regular health assessments. These will include physical exams and a review of the medicines they are taking. They will talk about how they are feeling.
The study included the following tests:
Blood draws
CT scans: Participants will lie in a machine that takes pictures of the body (maximum 3 per year)
Bone marrow biopsies: A small amount of marrow will be taken out of the participant s hip bone with a needle.
Optional lymph node biopsies: A small piece of the participant s tissue will be taken out with a needle.
The study will last at least 2 years.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis of CLL/SLL which is made according to the updated criteria of the NCI Working Group.
. Active disease as defined by at least one of the following (iwCLL consensus criteria):
. Must have designated hematologist/oncologist will assume care and provide venetoclax after the ramp-up phase is complete
. Must have G6PD testing performed to determine whether rasburicase can be given
. Must have HLA-testing performed to determine whether allopurinol hypersensitivity exists
. Age \>=18 years
. ECOG 0-2
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the rate of clonal shift during the ramp-up phase of venetoclax
Timeframe: 5 weeks.
Trial details
NCT IDNCT03986034
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
. Agreement to use acceptable methods of contraception for the duration of venetoclax treatment if sexually active and able to bear or beget children
Exclusion criteria
. Female patients who are currently pregnant or nursing
. Any uncontrolled active systemic infection
. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator s opinion, could compromise the subject s safety or put the study outcomes at undue risk
. Known additional malignancy that is progressing or requires active treatment.
-Note: Exceptions include basal cell carcinoma of skin, squamous cell carcinoma of skin, and in situ cervical cancer that has undergone potentially curative therapy. Further exceptions include other cancers from which the subject has been diseasefree for \> 2 years, cancers which will not limit survival to \< 2 years or cancers in remission receiving endocrine therapy.