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Venetoclax Treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

This study is looking at how the drug venetoclax affects cancer cells in people with chronic lymphocytic leukemia (CLL) that has come back or not responded to previous treatments. Researchers want to understand the genetic changes that happen in CLL cells during the first few weeks of venetoclax treatment. You may be able to join if you are an adult (18-85 years old) with CLL that meets certain criteria, including active disease symptoms like weight loss or extreme fatigue. The main goal is to see how much the cancer cells change genetically during the initial 5-week period of taking venetoclax. The study status is unclear, and it plans to enroll 75 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 75 participants.
What's involved
You will receive venetoclax at the NIH Clinical Center for about 5 weeks, with weekly visits. After this initial period, your local doctor will take over your care and continue venetoclax treatment.
Compensation
Not stated in the trial record.
Follow-up
You will have the option to follow-up at the NIH every 6 months (from when you started venetoclax) and if your disease progresses.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03986034

Early Clonal Dynamics During Venetoclax Treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Recruiting
PHASE2Ages 18–85InterventionalBasic science
National Heart, Lung, and Blood Institute (NHLBI)
~75 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:During Venetoclax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the rate of clonal shift during the ramp-up phase of venetoclax
Measured over 5 weeks.

Conditions

Chronic Lymphocytic Leukemia

Explore related trials

Chronic Lymphocytic LeukemiaG6PD GeneHLA Complex

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Christine E Gruessner, M.D. · PRINCIPAL_INVESTIGATOR · National Heart, Lung, and Blood Institute (NHLBI)

Who to contact

Ingrid C Frey
[email protected]
(301) 402-0797
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Weight loss \>=10% within the previous 6 months
Extreme fatigue
Fevers of greater than 100.5 degrees F for \>=2 weeks without evidence of infection
Night sweats for more than one month without evidence of infection
Evidence of progressive marrow failure as manifested by the development of, or worsening of
Anemia and/or thrombocytopenia
Massive or progressive splenomegaly
Massive nodes or clusters or progressive lymphadenopathy
Progressive lymphocytosis with an increase of \>50% over a 2-month period, or an anticipated doubling time of less than 6 months 3. Must have designated hematologist/oncologist will assume care and provide venetoclax after the ramp-up phase is complete 4. Must have G6PD testing performed to determine whether rasburicase can be given 5. Must have HLA-testing performed to determine whether allopurinol hypersensitivity exists 6. Age \>=18 years 7. ECOG 0-2 8. Agreement to use acceptable methods of contraception for the duration of venetoclax treatment if sexually active and able to bear or beget children 9. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty 10. Able to comprehend the investigational nature of the protocol and provide informed consent

Exclusion

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. 5. Richter s Transformation 6. Any prior therapy with BCL-2 inhibitors 7. Concomitant use of strong CYP3A4 inhibitors 8. Disease significantly affecting gastrointestinal function or absorption 9. Uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia 10. Concomitant systemic cancer directed therapy (e.g. immunotherapy, chemotherapy, radiotherapy) 11. Absolute neutrophil count (ANC) \<1000/microL, platelets (Plt) \<30,000/ microL 12. Serum bilirubin \>3 times upper limit of normal (ULN) 13. Severe psychiatric illness/social situations or cognitive impairment that would limit the patient s ability to tolerate and/or comply with study requirements
If the PI assesses the decreased ANC and/or Plt to be related to CLL involvement, patients may still be enrolled in the study, as cytopenias as expected to improve with treatment of CLL. Patients may receive supportive measures (e.g. transfusions, IVIG, growth factor support, etc.) to avoid severe cytopenias prior to and during therapy with venetoclax.

What this trial measures

  • Determine the rate of clonal shift during the ramp-up phase of venetoclax5 weeks.

    The planned analyses will include descriptive statistics on the proportions of clonal shift probability during the venetoclax ramp-up phase. The clonal shift probabilities will be estimated using the sample proportions and their inferences including confidence intervals and hypotheses testing will be evaluated