Is NCT03986034 recruiting in Bethesda, MD?

Yes, NCT03986034 is currently recruiting participants at its Bethesda, MD location. This chronic lymphocytic leukemia clinical trial is actively enrolling qualified participants.

How do I join the chronic lymphocytic leukemia clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chronic Lymphocytic Leukemia Clinical Trial in Bethesda, MD

About This Chronic Lymphocytic Leukemia Study in Bethesda

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.

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Who Can Participate

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):

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

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

Agreement to use acceptable methods of contraception for the duration of venetoclax treatment if sexually active and able to bear or beget children

Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty

Able to comprehend the investigational nature of the protocol and provide informed consent

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.

Richter s Transformation

Any prior therapy with BCL-2 inhibitors

Concomitant use of strong CYP3A4 inhibitors

Disease significantly affecting gastrointestinal function or absorption

Uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia

Concomitant systemic cancer directed therapy (e.g. immunotherapy, chemotherapy, radiotherapy)

Absolute neutrophil count (ANC) \<1000/microL, platelets (Plt) \<30,000/ microL

Serum bilirubin \>3 times upper limit of normal (ULN)

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT03986034) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Lymphocytic Leukemia Treatment Options in Bethesda, MD

If you're searching for chronic lymphocytic leukemia treatment options in Bethesda, MD, this clinical trial (NCT03986034) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced chronic lymphocytic leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic lymphocytic leukemia clinical trials near you to find additional studies recruiting in your area.

Chronic Lymphocytic Leukemia Clinical Trial in Bethesda, MD

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