Is NCT07685717 recruiting in Columbus, OH?

Yes, NCT07685717 is currently recruiting participants at its Columbus, OH location. This chronic lymphocytic leukemia/small lymphocytic lymphoma clinical trial is actively enrolling qualified participants.

Is participation in this Columbus 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/Small Lymphocytic Lymphoma Clinical Trial in Columbus, OH

Q: How do I join the chronic lymphocytic leukemia/small lymphocytic lymphoma clinical trial in Columbus?

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

About This Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Study in Columbus

This phase II trial studies how well pirtobrutinib works in treating elderly patients with chronic lymphocytic leukemia (CLL). Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib work by blocking the action of the BTK protein that signals cancer cells to multiply. These are very effective, tolerable, and commonly used to treat people with CLL, but they may lead to drug resistance over time. Pirtobrutinib, also a BTK inhibitor, may work better in treating elderly patients with CLL.

Sponsor: Jennifer Woyach

Who Can Participate

Inclusion Criteria

Men and women ≥ 75 years of age

Diagnosis of CLL/small lymphocytic lymphoma (SLL) meeting criteria established in the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines

Must be treatment-naive: Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control. For radiation, broad field radiation (≥ 30% of bone marrow or whole brain radiotherapy) must be completed 14 days before study enrollment; palliative limited field radiation must be completed 7 days prior to study enrollment. For rituximab, washout of 2 weeks is required prior to study enrollment

Must require treatment according to 2018 iwCLL guidelines

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy

Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN with documented liver involvement and/or Gilbert's syndrome

Creatinine clearance ≥ 30 mL/minute using Cockcroft-Gault formula

Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin time (PT) or (international normalized ratio \[INR\]) not greater than 2.0 × ULN

Absolute neutrophil count (ANC) ≥ 0.75 x 10\^9 (on or within 7 days of cycle 1 day 1 \[C1D1\] before treatment); the patient may enroll below threshold if there is documented bone marrow involvement of CLL considered to impair hematopoiesis. Granulocyte colony-stimulating factor (GCSF) support is allowed

Platelet count ≥ 30 x 10\^9 not requiring transfusion support (on or within 7 days of C1D1 before treatment); the patient may enroll below this threshold if there is documented bone marrow involvement of CLL considered to impair hematopoiesis

Hemoglobin ≥ 6 mg/dL not requiring transfusion support or growth factors (on or within 7 days of C1D1 before treatment); the patient may enroll below this threshold if there is documented bone marrow involvement of CLL considered to impair hematopoiesis

If patients require transfusion support due to bone marrow involvement of CLL, they must be responsive to transfusion support

Male patients are sexually active with a woman of childbearing potential must use highly effective methods of contraception during treatment

The patient is able to take oral medications

Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information

Exclusion Criteria

Active Richter's transformation (i.e. within 6 months of active therapy, or requiring treatment for Richter's transformation)

Malabsorption syndrome or inability to absorb pirtobrutinib

Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, those with uncontrolled arrhythmia, and those patients who experienced an myocardial infarction (MI) within 3 months of screening or acute coronary syndrome within 2 months of screening are not eligible

Documented left ventricular ejection fraction (LVEF) by any method of ≤ 40% in the 12 months prior to randomization

Prolongation of QT interval corrected for heart rate (QTcF) \> 470 msec

Major surgical procedure within 28 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug

Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)

History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug

Patients who have tested positive for human immunodeficiency virus (HIV) are excluded due to risk of opportunistic infections with both HIV and Bruton Tyrosine Kinase (BTK)-inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrollment

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

Hepatitis B virus (HBV):

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 starting study therapy

Patients who are HBV deoxyribonucleic acid (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

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

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

Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)

Active second malignancy unless in remission and with life expectancy \> 2 years

Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists

Vaccination with live vaccines 28 days prior to registration for study screening

Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components

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 Columbus?

Yes, this clinical trial (NCT07685717) has an active research site in Columbus, OH 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/Small Lymphocytic Lymphoma Treatment Options in Columbus, OH

If you're searching for chronic lymphocytic leukemia/small lymphocytic lymphoma treatment options in Columbus, OH, this clinical trial (NCT07685717) 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 Columbus research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced chronic lymphocytic leukemia/small lymphocytic lymphoma 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/small lymphocytic lymphoma clinical trials near you to find additional studies recruiting in your area.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Clinical Trial in Columbus, OH

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