Chronic Lymphocytic Leukemia Clinical Trial
Clonal Evolution of B Cells in High-risk CLL After Idelalisib-rituximab
Summary
The purpose of the study is to assess the evolution of B cells at a genetic and surface-marker level in high-risk leukemia-cll/" >CLL after idelalisib-rituximab treatment. The targeted population includes 20 subjects ages 18 or older diagnosed with high-risk CLL. This will include patients with relapsed or refractory disease who require therapy with idelalisib and rituximab as per FDA label. This is an observational study for peripheral blood samples of these patients collected at pre-determined time points.
Eligibility Criteria
Inclusion Criteria:
Age over 18
Ability to provide informed consent
Ability to provide peripheral blood samples
Diagnosis of CLL
Indication(s) for CLL therapy
At least one criterion for high-risk disease
Disease refractory (e.g., no response) to at least one round of chemotherapy
Disease that has relapsed (i.e., returned) after at least one round of chemotherapy
Proven presence of the 17p deletion within CLL cells
Planned receipt of idelalisib-rituximab as per FDA guidelines and patient's oncologists
Exclusion Criteria:
Patients who do not meet the diagnostic criteria for CLL or at least one indication for treatment.
Patients who are receiving idelalisib with an off-label indication
Patients who do not or cannot provide informed consent to donate peripheral blood tumor samples to our stem cell core facility
Patients who do not provide informed consent to collect clinical, prognostic, and outcomes data during the time period that they are treated with idelalisib-rituximab
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There is 1 Location for this study
Philadelphia Pennsylvania, 19104, United States
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