Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18 - 69
Clinical summary
Summary
This study is to determine the clinical minimum residual disease (MRD) response with the combination of ibrutinib plus venetoclax in subjects with treatment-naive chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma
Conditions
This trial is treating people with Chronic Lymphocytic Leukaemia, Chronic Lymphocytic Leukaemia
Eligibility
Inclusion
- Diagnosis of CLL/SLL that meets 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria (Hallek et al), with active disease meeting at least 1 IWCLL criteria for requiring treatment.
- Measurable nodal disease by computed tomography (CT)
- Adequate hepatic, and renal function
- Adequate hematologic function
- absolute neutrophil count >750/µL
- platelet count >30,000 /μL
- hemoglobin >8.0 g/dL
Exclusion
- Any prior therapy used for treatment of CLL/SLL
- Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for tumor lysis syndrome (TLS)
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
Pharmacyclics
Scientific Title
Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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