Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
The main purpose of this study is to assess the efficacy and safety of three dose levels of Pirtobrutinib targeted therapy in people with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma who have received 1-3 lines prior lines of treatment that included a covalent BTK inhibitor.
Eligible participants will be randomly assigned to receive one of three different doses of Pirtobrutinib, which is a BTK inhibitor that will be administered orally.
The study is expected to last approximately 3 years.
Conditions
This trial is treating people with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
Eligibility
Inclusion
- Have confirmed diagnosis of CLL/SLL as defined by these iwCLL 2018 criteria.
- Have received prior CLL/SLL treatment
- Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
- Have received a covalent BTK inhibitor
- Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
- Capable of swallowing oral study medication.
- Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Loxo Oncology, Inc.
Scientific Title
A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor
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