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New treatment option for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Official title Pirtobrutinib for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia
ClinicalTrials.gov ID: NCT07685717
What this study is testing
What is Pirtobrutinib?
Pirtobrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia/small lymphocytic lymphoma.
Also referred to as 5-Amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-((2S)-1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide, BTK Inhibitor LOXO-305.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join if
- 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...
- Must be treatment-naive: Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of...
- Must require treatment according to 2018 iwCLL guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.