Actively Recruiting
Clonal Dynamics of Chronic Lymphocytic Leukaemia Treated With Pirtobrutinib After Previous Treatment With Zanubrutinib
Led by Peter MacCallum Cancer Centre, Australia · Updated on 2025-08-06
40
Participants Needed
3
Research Sites
312 weeks
Total Duration
On this page
Sponsors
P
Peter MacCallum Cancer Centre, Australia
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicentre single-arm prospective phase II trial evaluating pirtobrutinib in the treatment of relapsed/refractory (R/R) Chronic Lymphocytic Leukaemia (CLL) patients who have previously received zanubrutinib, and to specifically evaluate Bruton Tyrosine Kinase (BTK) mutational status (clonal dynamics) before, during and after treatment with pirtobrutinib.
CONDITIONS
Official Title
Clonal Dynamics of Chronic Lymphocytic Leukaemia Treated With Pirtobrutinib After Previous Treatment With Zanubrutinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has provided written informed consent using the PIPOZA Patient Information and Consent Form (PICF)
- Confirmed diagnosis of CLL according to iwCLL 2018 criteria, including atypical immunophenotype
- Prior systemic therapy including zanubrutinib as the most recent therapy with at least one 28-day cycle
- Indication for second- or subsequent-line treatment as defined by iwCLL 2018 criteria
- Age 18 years or older at time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate bone marrow function: absolute neutrophil count > 0.75 x 10^9/L; platelets ≥ 30 x 10^9/L; haemoglobin ≥ 70 g/L
- Normal liver function: total bilirubin ≤ 1.5x ULN or ≤ 3.0x ULN with liver involvement; ALT and AST < 3.0x ULN or ≤ 5.0x ULN with liver involvement
- Adequate kidney function with creatinine clearance > 30 mL/min
- Ability to swallow tablets
- At least 24-hour washout from zanubrutinib before starting pirtobrutinib
- Prior treatment-related adverse events must have recovered to Grade ≤ 1 or baseline except alopecia and Grade 2 peripheral neuropathy
- Women of childbearing potential must have a negative pregnancy test within 14 days prior to starting treatment
- Men and women of childbearing potential must agree to use highly effective contraception during treatment and 6 months after
- Patient understands and agrees to comply with trial procedures and protocol requirements
You will not qualify if you...
- Known or suspected Richter's Transformation or other aggressive lymphoma prior to registration
- Known or suspected central nervous system involvement
- Stem cell transplant or CAR-T therapy within past 60 days or ongoing complications from these treatments
- Positive HIV serology
- Concurrent anticancer therapy
- Use of ≥ 20 mg prednisone daily or equivalent steroid within 7 days prior to starting pirtobrutinib
- Vaccination with live vaccine within 28 days before registration
- Prolonged QT interval (QTcF > 470 msec) without safe correction
- Pregnant or breastfeeding women, or planning pregnancy/breastfeeding during study or shortly after
- Active second malignancy
- Significant malabsorption syndrome affecting oral drug absorption
- Active hepatitis B or C infection without confirmed viral clearance
- Known active cytomegalovirus infection
- Other uncontrolled significant medical conditions or infections posing risk
- Active uncontrolled autoimmune cytopenia requiring new or escalated therapy within 4 weeks
- Prior treatment with pirtobrutinib
- Need for therapeutic anticoagulation with warfarin or vitamin K antagonists
- Known hypersensitivity to pirtobrutinib components
- Significant cardiovascular disease including recent unstable angina, myocardial infarction, severe heart failure, or uncontrolled arrhythmias
- History of major bleeding or stroke within 6 months
- Major surgery within 4 weeks prior to registration
- Current treatment with strong P-glycoprotein inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
2
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Not Yet Recruiting
3
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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