Is NCT06651970 recruiting in Philadelphia, PA?

Yes, NCT06651970 is currently recruiting participants at its Philadelphia, PA location. This chronic lymphocytic leukemia clinical trial is actively enrolling qualified participants.

Is participation in this Philadelphia 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 Philadelphia, PA

Q: How do I join the chronic lymphocytic leukemia clinical trial in Philadelphia?

To join this clinical trial in Philadelphia, 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 Study in Philadelphia

This will be a global Phase IV, open-label, randomised study to evaluate the safety and tolerability of acalabrutinib (monotherapy, 100 mg orally \[po\], twice daily \[bd\]) compared to investigator's choice of treatment, in patients with CLL (TN or R/R) and moderate to severe cardiac impairment. All patients will have cardiac impairment as defined by LVEF of \< 50%. Randomisation will be stratified by LVEF \> 40% vs ≤ 40% to stratify for moderate and severe cardiac impairment, which for this s

Sponsor: AstraZeneca

Who Can Participate

Inclusion Criteria

Men and women ≥ 18 years of age, at the time of signing the informed consent.

Eastern Cooperative Oncology Group performance status of 0 to 3

Meet at least one of the following cardiovascular inclusion criteria: - Left ventricular ejection fraction (LVEF) \< 50% as assessed by local ECHO at screening. - History of heart failure or meeting Universal Definition of Heart Failure at screening, regardless of current LVEF. - History of ischaemic heart disease (IHD) including acute coronary syndrome, myocardial infarction, or coronary revascularization (percutaneous coronary intervention/stent or coronary artery bypass surgery). - Diagnosis of cardiomyopathy - Ongoing clinically significant (symptomatic or requiring intervention) cardiac arrhythmia, including atrial fibrillation or other arrhythmias. - History of moderate or severe cardiac valvular diseases as documented per cardiac imaging

Diagnosis of CLL

Treatment naïve or relapsed/refractory patients who have received no more than 2 prior lines of systemic anti-CLL treatment.

Active disease per iwCLL 2018 criteria that requires treatment.

Meet the following laboratory parameters:

Absolute neutrophil count (ANC) ≥ 500 cells/μL (0.50 × 109/L).

Platelet count ≥ 30,000 cells/μL (30 × 109/L).

Serum aspartate aminotransferase and ALT ≤ 3.0 × ULN.

Total bilirubin ≤ 1.5 × ULN unless directly attributable to Gilbert's syndrome.

Estimated creatinine clearance (ie, estimated glomerular filtration rate \[eGFR\] using Cockcroft-Gault) ≥ 40 mL/min, or serum creatinine ≤ 2 × ULN.

Women and men who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib.

Patients must be willing and able to adhere to the study visit schedule, understand, and comply with other protocol requirements, and provide written informed consent and authorisation to use protected health information (in accordance with national and local patient privacy regulations). Note: vulnerable patients, as defined in the ICH GCP, are not allowed on this protocol (eg, prisoners or institutionalised patients).

Exclusion Criteria

Known active CNS leukaemia, leptomeningeal disease or spinal cord compression. In case of R/R patients with prior history of CNS localisation of leukaemia who received treatment are eligible provided that there is no evidence of CNS involvement at study entry as documented by cerebrospinal fluid (CSF) cytology and/or brain MRI.

Ongoing Richter's transformation.

Prior exposure to a BTKi.

Major surgery within 30 days before first dose of study treatment.

Uncontrolled haemolytic anaemia.

Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study treatment.

Received a live virus vaccination within 28 days of first dose of study treatment.

History of or ongoing confirmed PML.

History of prior malignancy except for the following:

Prior history of malignancy with no evidence of active disease present for more than 3 years before screening or felt to be at low risk for recurrence by treating physician. (b) Adequately treated lentigo maligna melanoma without current evidence of disease or adequately resected non-melanomatous skin cancer (ie, basal cell carcinoma or squamous cell carcinoma of the skin). (c) Curatively treated in situ carcinoma of the cervix or carcinoma in situ of the prostate at any time prior to study without current evidence of disease. 10 Unable to swallow tablets or malabsorption syndrome, or disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. 11 Active uncontrolled systemic infection (bacterial, fungal, viral or other) or clinically significant localised infection. 12 Known history of infection with human immunodeficiency virus (HIV). 13 Serologic status reflecting active HepB or HepC infection. (a) Patients with HepB core antibody positive who are surface antigen negative or who are HepC antibody positive will need to have a negative polymerase chain reaction (PCR) result before randomisation and must be willing to undergo deoxyribonucleic acid (DNA) PCR testing during the study. (b) Patients who are HepB surface antigen positive or HepB PCR positive and those who are HepC PCR positive will be excluded. 14 History of stroke or intracranial haemorrhage within 6 months prior to randomisation. 15 History of bleeding diathesis (eg, haemophilia, von Willebrand disease). 16 Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study treatment. Direct anti-X (DOACs) or low molecular weight heparins (LMWH, eg, enoxaparin) on stable dosing schedule is allowed. 17 Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor/inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study treatment is prohibited. 18 Breastfeeding or pregnant. 19 Concurrent participation in another therapeutic clinical trial. 20 Uncontrolled cardiac/cardiovascular disease including the following:

Baseline cardiac troponin (cTnI or cTnT or hs-cTn) levels greater than the upper limit of normal (per the local laboratories reference range) that is due to an acute coronary event and cannot be fully explained by non-ischaemic conditions.

Uncontrolled cardiac tachyarrhythmias (sinus, atrial or ventricular) that require new/additional therapy within the last month.

Clinically significant QT prolongation defined as QT interval corrected by Fridericia's formula (QTcF) values; QTcF \> 500 ms.

Any of the following within the last 3 months: i. Unstable IHD: percutaneous coronary intervention, coronary artery bypass surgery, or an episode of acute coronary syndrome including acute myocardial infarction and unstable angina pectoris. ii. Major cardiac surgery/procedures or valvular surgery. iii. Hospitalization due to heart failure. 21 Uncontrolled hypertension despite optimal management 22 Current life-threatening illness, medical conditions, organ system dysfunction or lifestyle habits which, in the investigator's opinion, could compromise the patient's safety or ability to adhere to the study protocol.

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 Philadelphia?

Yes, this clinical trial (NCT06651970) has an active research site in Philadelphia, PA 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 Philadelphia, PA

If you're searching for chronic lymphocytic leukemia treatment options in Philadelphia, PA, this clinical trial (NCT06651970) 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 Philadelphia research site is actively enrolling participants for this phase 4 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 Philadelphia, PA

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