None listed
Conditions
Brief summary
The purpose of this study is to evaluate the outcomes of immunoglobulin (Ig) therapy in people who have non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukaemia (CLL). In Australia, Ig therapy is commonly used to prevent infection in patients with CLL and NHL, but there is limited evidence from clinical studies to guide doctors on which patients are most likely to benefit, when treatment should start, and for how long it should continue. Whos it for? Individuals 18 years or older with newly diagnosed B-cell Non-Hodgkin lymphoma or Chronic Lymphocytic Leukaemia. Study Details Participants will attend their medical appointments at the discretion of their treating clinician. Data will be collected for the ICAN database at six-monthly intervals (6, 12,18 and 24 months) starting from the date of diagnosis. Additional assessments involve questionnaires about the participants quality of life. Participants of the biobank sub-study will be asked to provide non-fasting blood samples (30mL) at baseline (before treatment), 6-months, 12-months and 24-months. Once collected the blood samples will be stored for future testing and analysis. Results from this study will be valuable in assisting research that improves the prevention, diagnosis and treatment of infections in people with these illnesses.
Interventions
Patients who are diagnosed with chronic lymphocytic leukaemia (CLL) or non-Hodgkin lymphoma (NHL), and participate in the Lymphoma and Related Disease Registry (LaRDR) will have their immunoglobulin and antibiotic use, and infection data entered into the study-specific database. These patients have a greater risk of infections because their level of protective antibodies is affected by their disease and treatment. Immunoglobulin (Ig) therapy is commonly used to prevent or treat infections in the
Patients who are diagnosed with chronic lymphocytic leukaemia (CLL) or non-Hodgkin lymphoma (NHL), and participate in the Lymphoma and Related Disease Registry (LaRDR) will have their immunoglobulin and antibiotic use, and infection data entered into the study-specific database. These patients have a greater risk of infections because their level of protective antibodies is affected by their disease and treatment. Immunoglobulin (Ig) therapy is commonly used to prevent or treat infections in these patients by replacing their missing antibodies. This study will utilise the same opt-out consent model as the LaRDR, where eligible patients are informed about the nature of the registry through a patient information brochure. Participants are then able to opt-out of the registry before, or any time after, joining the registry by informing their treating clinicians or contacting registry staff. The ICAN study will collect ‘real world’ up-to-date Australian clinical and laboratory information on immunoglobulin and antibiotic use in these patients to guide policy and clinical practice; plan and deliver care; and monitor practice, costs, and outcomes. Data will be collected at the following time points: diagnosis (baseline) 6-months, 12-months, 18-months and 24-months. The biobank sub-study will collect blood samples from 50 CLL and NHL patients at Victorian sites for routine and advanced immune profiling. Biobank participants will be provided with a patient informed consent form, which will be signed and dated by the participant before sample collection. Biobank participants will be asked to provide 30mL of non-fasting blood (serum and EDTA whole blood) from the antecubital vein at baseline (before treatment), 6-months, 12-months and 24-months. Blood will be collected into specific tubes (EDTA tube and Serum separator tube) for processing and isolation of plasma, serum, peripheral blood mononuclear cell (PBMC) and circulating cell-free nucleic acids.
Sponsors
Monash University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Newly diagnosed with CLL or B-cell NHL A participant in the LaRDR
Exclusion criteria
Patients who decline to participate For Biobank participants: Patients who have commenced treatment
Outcome results
None listed