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New treatment option for Chronic Lymphocytic Leukemia
Official title Clonal Dynamics of Chronic Lymphocytic Leukaemia Treated With Pirtobrutinib After Previous Treatment With Zanubrutinib
ClinicalTrials.gov ID: NCT06812715
What this study is testing
What is Pirtobrutinib?
Pirtobrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia.
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 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient has provided written informed consent using the PIPOZA Patient Information and Consent Form (PICF)
- Confirmed diagnosis of CLL according to iwCLL 2018 criteria, also including CLL with atypical immunophenotype
- Prior systemic therapy, which must include zanubrutinib as the most recent prior line of therapy. Patients must have received at least one cycle (28...
- Patients must have an indication for second- or subsequent-line treatment in the opinion of the investigator as defined by iwCLL 2018 criteria...
- Where the original indication for treatment has not resolved with initial therapy and it is considered reasonable to initiate second-line treatment...
You likely can't join if
- Known or suspected Richter's Transformation to diffuse large B-cell lymphoma, prolymphocytic leukaemia, or Hodgkin lymphoma at any time prior to...
- Known or suspected history of central nervous system involvement
- History of allogeneic or autologous stem cell transplant or chimeric antigen receptor T-cell (CAR-T) therapy within the past 60 days and/or with any...
- Active graft versus host disease
- Cytopenias from incomplete blood cell count recovery post-transplant or CAR-T therapy
- Need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity Grade \> 1 from CAR-T therapy
See the full eligibility criteria
Who can join
- Patient has provided written informed consent using the PIPOZA Patient Information and Consent Form (PICF)
- Confirmed diagnosis of CLL according to iwCLL 2018 criteria, also including CLL with atypical immunophenotype
- Prior systemic therapy, which must include zanubrutinib as the most recent prior line of therapy. Patients must have received at least one cycle (28 days) of zanubrutinib
- Patients must have an indication for second- or subsequent-line treatment in the opinion of the investigator as defined by iwCLL 2018 criteria, including:
- Where the original indication for treatment has not resolved with initial therapy and it is considered reasonable to initiate second-line treatment without waiting for formal disease progression to be manifest
- Where the rate of disease progression is considered rapid, and initiation of subsequent therapy is considered acceptable before formal progression where there is substantial persisting disease burden
- Age 18 years of age or older at time of signing the PICF
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Must have adequate bone marrow function, as defined below:
- Absolute neutrophil count \> 0.75 × 109/L; if marrow is known to be infiltrated by CLL, granulocyte-colony stimulating factor (G-CSF) support may be used to achieve eligibility criteria
- Platelets ≥ 30 × 109/L independent of transfusions within 7 days prior to screening assessment
- Haemoglobin ≥ 70 g/L independent of transfusions within 7 days prior to screening assessment
- Normal hepatic function defined as:
- Total bilirubin ≤ 1.5× upper limit of normal (ULN) or ≤ 3.0 x ULN with documented liver involvement and/or Gilbert's Disease
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3.0 × ULN or ≤ 5.0 × ULN with documented liver involvement
- Adequate renal function defined as creatinine clearance of \> 30 mL/minute calculated by Cockroft-Gault formula or using biochemical or nuclear medicine techniques
- Ability to swallow tablets
- Patients must have had a zanubrutinib washout period of at least 24 hours prior to the planned start date of pirtobrutinib on Day 1 Cycle 1
- Prior treatment-related adverse events must have recovered to Grade ≤ 1 or pretreatment baseline with the exception of alopecia and Grade 2 peripheral neuropathy
- Women of childbearing potential defined as not postmenopausal for at least 2 years or surgically sterile must have a negative serum pregnancy test documented within 14 days prior to planned started date of pirtobrutinib...
- Men with partners of childbearing potential or women of childbearing potential must agree to use a highly effective contraceptive method of birth control during study treatment and for at least 6 months following the...
- Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally
- Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant
- Intrauterine device Intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomised partner
- Sexual abstinence: Considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual...
- The patient understands the purpose of the trial and procedures required for the trial which includes compliance with the protocol requirements and restrictions listed in the PICF and in this protocol
What rules you out
- Known or suspected Richter's Transformation to diffuse large B-cell lymphoma, prolymphocytic leukaemia, or Hodgkin lymphoma at any time prior to registration
- Known or suspected history of central nervous system involvement
- History of allogeneic or autologous stem cell transplant or chimeric antigen receptor T-cell (CAR-T) therapy within the past 60 days and/or with any of the following:
- Active graft versus host disease
- Cytopenias from incomplete blood cell count recovery post-transplant or CAR-T therapy
- Need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity Grade \> 1 from CAR-T therapy
- Ongoing immunosuppressive therapy
- Positive serology for human immunodeficiency virus (HIV) test in Screening 5. Concurrent anticancer therapy 6\. Use of ≥ 20 mg prednisone QD or equivalent dose of steroid per day within 7 days prior to the planned...
- 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...
- Manual correction for underlying bundle branch block is allowed Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker 9. Female...
- Hepatitis B virus (HBV): positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (anti-HBc). If anti-HBc positive with surface antigen negative, patient will need to have a negative result for...
- 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 start of study therapy. Patients...
- Unstable angina or acute coronary syndrome within the past 2 months prior to registration
- History of myocardial infarction within 3 months prior to registration
- Documented left ventricular ejection fraction by any method of ≤ 40% in the 12 months prior to registration
- ≥ Grade 3 New York Heart Association functional classification system of heart failure
- Uncontrolled or symptomatic arrhythmias 21. History of uncontrolled or symptomatic arrhythmias including Grade ≥ 3 arrhythmia on a prior BTKi 22. History of major bleeding on a prior BTKi NOTE: Major bleeding is defined...
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. 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.