Is NCT07428707 recruiting in Bethesda, MD?

Yes, NCT07428707 is currently recruiting participants at its Bethesda, MD location. This chronic lymphocytic leukemia (cll) clinical trial is actively enrolling qualified participants.

How do I join the chronic lymphocytic leukemia (cll) 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 (CLL) Clinical Trial in Bethesda, MD

About This Chronic Lymphocytic Leukemia (CLL) Study in Bethesda

Background: Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. Pirtobrutinib is a drug approved to treat CLL and SLL after 2 previous treatments. Researchers want to know how this drug affects the immune system in those who have not yet started other treatments for CLL or SLL. Objective: To test pirtobrutinib as a first-line treatment for CLL or SLL. Eligibility: People aged 18 years and older with untreated CLL or SLL. Design: Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and tests of their heart function. They will have a lymph node biopsy: A large needle will be inserted into a lymph node to collect a small piece of tissue. Pirtobrutinib is a tablet taken by mouth. Participants will take 2 to 4 tablets daily in 4-week cycles. Participants will have clinic visits once every 4 weeks for the first 3 months. Then they will be seen once every 3 months. Imaging scans, lymph node biopsy, and other tests will be repeated at various study visits. A bone marrow biopsy (collection of soft tissue from inside a bone) may be done if there is no evidence of disease after 1 year of treatment with the study drug. Participants may opt to have cancer and immune cells collected from their blood. The cells will be used for research. Participants will have a clinic visit 1 month after their last dose of the study drug. Then they will have follow-up visits or phone calls every 6 to 12 months....

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

Who Can Participate

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Stated willingness to comply with all study procedures

Age \>=18 years

Confirmed diagnosis of CLL or SLL according to International Workshop on CLL (iwCLL) guidelines

Coexpression of CD5, CD19, CD20, and CD23 expression and light-chain restriction; CD23 dim or negative expression is acceptable as long as other parameters are consistent with a diagnosis of CLL.

CLL: clonal B-lymphocytosis \>=5,000 cells/mL OR SLL: lymphadenopathy with the tissue morphology of CLL but that are not leukemic, \<5,000 cells/mL

Active disease requiring treatment according to iwCLL guidelines

Measurable disease characterized by \>=1 of the following:

Lymphadenopathy: \>=1 lymph node measuring \>=1.5 cm in the greatest diameter

Splenomegaly: spleen measuring \>13 cm in craniocaudal length

Lymphocytosis: \>=5,000 B cells/microL

Bone marrow infiltration: CLL comprising \>= 30% of all cells

Previously untreated CLL with \>=1 LN amenable to core-needle biopsy

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

The patient has adequate organ function for all of the following criteria, as defined below:

System: Hepatic

Laboratory Value: ALT or AST: \<= 3 x the ULN or \<= 5 x ULN with documented liver involvement

Laboratory Value: Total bilirubin: \<= 1.5 x ULN or \<= 3 x ULN with documented liver involvement and/or Gilbert s Disease

System: Renal --Laboratory Value: Serum creatinine: Calculated creatinine clearance \>= 30 ml/min according to Cockcroft/Gault Formula: \[(140-age) x body weight (kg) x 0.85 (if female)\]/ \[serum creatinine (mg/dL) x 72\]

System: Hematologic

Laboratory Value: Hemoglobin: \>= 8 g/dL (\>= 80 g/L)

Laboratory Value: ANC: \>= 0.75 x 10\^9/L

Laboratory Value: Platelets: \>= 50 x 10\^9/L Notes: Hgb and platelets: independent of transfusions within 7 days of Screening assessment. ANC: independent of growth factor support within 7 days of Screening assessment. Criteria must be met on C1D1 without transfusion/G-CSF within 7 days of assessment. Abbreviations: ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST =aspartate aminotransferase; ULN = upper limit of normal.

Adequate coagulations, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or international normalized ratio (INR) not greater than 1.5 X ULN.

Willingness of WOCBP and their partners to observe highly effective birth control methods for the duration of treatment and for 1 month following the last dose of study treatment.

Ability to take oral medication and be willing to adhere to the study drug regimen

Agreement to adhere to Lifestyle Considerations throughout study duration

Able to understand and willing to sign a written informed consent document.

Exclusion Criteria

Diagnosis of Richter Transformation

Documented CNS involvement

Pregnancy or plan to become pregnant during the study or within 1 month of the last dose of study treatment. WOCBP must have a negative serum pregnancy test.

Lactation or plan to breastfeed during the study or within 1 week of the last dose of study treatment.

Known active cytomegalovirus (CMV) infections. Unknown or negative status are eligible.

Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:

Patients with positive hepatitis B surface antigen (HBsAg) are excluded.

Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require a negative hepatitis B polymerase chain reaction (PCR) evaluation before randomization.

Patients who are HBV DNA PCR positive will be excluded.

Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded.

Patients who have tested positive for Human Immunodeficiency Virus (HIV) and have a detectable viral load and/or a CD4 count \<350 are excluded due to risk of opportunistic infections with both HIV and BTK inhibitors. Eligible patients with HIV must be stable on antiretroviral therapy \>=4 weeks prior to study entry. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrollment.

Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug. (e.g., gastric bypass surgery, gastrectomy).

Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and medical monitor may pose a risk for patient participation. Screening for chronic conditions is not required.

Stroke or intracranial hemorrhage within 6 months of screening

Hypertensive urgency or emergency

Active, clinically significant cardiovascular disease including:

Unstable angina or acute coronary syndrome within the past 2 months prior to screening

Documentation of LVEF by any method of \<= 40% in the 12 months prior to screening

Uncontrolled or symptomatic arrhythmias

Class 3 or 4 congestive heart failure as defined by New York Heart Association Functional Classification

Myocardial infarction, unstable angina or acute coronary syndrome within 3 months of screening.

Prolongation of the QT interval corrected for heart rate (QTcF) \> 470 msec. QTcF is calculated using Fridericia s Formula (QTcF): QTcF=QT/(RR\^0.33) Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator s discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation. \- Correction for underlying bundle branch block (BBB) allowed. Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker

Known allergy/sensitivity to pirtobrutinib or any of the excipients (hydroxypropyl methylcellulose acetate succinate, microcrystalline cellulose, mannitol, sodium starch glycolate, and magnesium stearate.).

History of bleeding diathesis (e.g. von Willebrand disease or hemophlia)

Has received a live vaccine or live-attenuated vaccine within 28 days before the first dose of pirtobrutinib. Administration of killed vaccines are allowed.

Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist are excluded. Direct oral anticoagulants (DOACs) are allowed.

Diagnosis of primary immunodeficiency or is receiving chronic systemic steroid therapy (in dosing \>20 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.

Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid)

Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic purpura \[ITP\]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts.

Active second malignancy unless in remission and with life expectancy \>2 years. Note: Participants are eligible if they have prostate cancer under active surveillance or observation.

Has not adequately recovered after 4 weeks from major surgery or has ongoing surgical complications.

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant s participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.

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 (NCT07428707) 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 (CLL) Treatment Options in Bethesda, MD

If you're searching for chronic lymphocytic leukemia (cll) treatment options in Bethesda, MD, this clinical trial (NCT07428707) 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 clinical trial. You'll receive care from experienced chronic lymphocytic leukemia (cll) 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 (cll) clinical trials near you to find additional studies recruiting in your area.

Chronic Lymphocytic Leukemia (CLL) Clinical Trial in Bethesda, MD

Expert Care in Bethesda

IRB Approved

No-Cost Care

Apply for This Bethesda Location

Why Participate?

Simple Process