Is NCT06520098 recruiting in Durham, NC?

Yes, NCT06520098 is currently recruiting participants at its Durham, NC location. This chronic lymphocytic leukemia clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Durham, 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 Durham 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 Durham, NC

About This Chronic Lymphocytic Leukemia Study in Durham

People who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) are often treated with ibrutinib, acalabrutinib, or zanubrutinib. These are pills that are taken by mouth. This type of pill is called "Bruton Tyrosine Kinase Inhibitor" or BTKi. Another treatment for CLL/SLL is a different pill called venetoclax. The purpose of this study is to compare continuing the current treatment with BTKi alone, as long as it is working, to another arm of treatment which adds venetocla

Sponsor: VA Office of Research and Development

Who Can Participate

Inclusion Criteria

CLL or SLL diagnosis

Patients must have been diagnosed with CLL (\> 5000 B-cells per uL of peripheral blood at any point during the course of their disease) or small lymphocytic lymphoma (SLL) with \<5000 B-cells per µL of blood but with disease-associated lymphadenopathy by 2018 IWCLL criteria.

Prior treatment

Patients must be currently receiving CLL/SLL directed therapy with a BTKi (i.e., ibrutinib, acalabrutinib, zanubrutinib) for at least six months.

The dose of BTKi must be stable for at least the past three months.

Age 18 years

ECOG performance status 0-2

Detectable or measurable CLL/SLL in blood or imaging during the screening period. Detectable CLL/SLL in the blood is defined either by elevation in absolute lymphocyte count or by diagnostic flow cytometry from blood demonstrating presence of CLL cells.

Low TLS risk, defined as having all lymph nodes less than 5 cm in diameter (radiographically) and absolute lymphocyte count less than 25 x 109/L in blood, within 30 days of enrollment.

Required initial laboratory values

Absolute Neutrophil Count (ANC) 1,000/mm3 except if due to bone marrow involvement

Platelet Count (untransfused) 30,000/mm3 except if due to bone marrow involvement

Calc. Creatinine Clearance 40 mL/min (by Cockcroft-Gault)

Bilirubin 1.5 x upper limit of normal (ULN) except if due to liver involvement, hemolysis, or Gilbert's disease

AST / ALT 2.5 x upper limit of normal (ULN) except if due to liver involvement

Patients must be able to swallow oral medications and not have the following conditions: disease significantly affecting gastrointestinal absorption, resection of the stomach or small bowel, partial or complete bowel obstruction.

Patients must be able to receive either a xanthine oxidase inhibitor or rasburicase

Exclusion Criteria

Prior treatment

Patients must not have progression of CLL/SLL on BTKi therapy prior to initiation of the study therapy.

Patients must not have received the combination of BTKi + venetoclax previously.

Comorbid conditions or other active diseases

Patients must not have any history of Richter's transformation or prolymphocytic leukemia.

If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable and be on suppressive therapy, if indicated.

Please note: IVIG can cause a false positive hepatitis B serology. If patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician.

If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load.

Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible.

Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy are eligible for this trial.

Concomitant medications

Patients must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study.

Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not recommended on this study. Patients on strong CYP3A inhibitors must discontinue the drug for 14 days prior to registration on the study or discuss with the study principal investigator.

Chronic concomitant treatment with strong CYP3A4/5 inducers is not recommended. Patients must discontinue the drug 14 days prior to registration on the study or discuss with the study principal investigator.

Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily.

Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics

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 Durham?

Yes, this clinical trial (NCT06520098) has an active research site in Durham, NC 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 Durham, NC

If you're searching for chronic lymphocytic leukemia treatment options in Durham, NC, this clinical trial (NCT06520098) 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 Durham 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 Durham, NC

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