Prospective Multicentre Observational Registry Of Treatments And Outcomes In Patients With Chronic Lymphocytic Leukaemia Or Indolent Non Hodgkin's Lymphoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Indolent Non Hodgkin's Lymphoma (iNHL)
- Sponsor
- Astellas Pharma International B.V.
- Enrollment
- 25
- Locations
- 8
- Primary Endpoint
- Proportion of patients on different types of pharmacological regimen for treatment of Chronic Lymphocytic Leukaemia (CLL) or Indolent Non Hodgkin's Lymphoma (iNHL)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to document the pharmacological treatment strategies used in treatment naïve and previously treated relapsed/refractory iNHL/CLL patients in the Middle East and North African (MENA) region. This study will also record encountered tumor subtype and stage and the instituted pharmacological treatments, as well as assess the clinical outcomes of treatments.
Detailed Description
Patients will be followed up to 30 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed consent
- •CLL patients or
- •iNHL patients
- •Clinical decision made to initiate or adapt treatment of CLL/iNHL("Need to treat")
Exclusion Criteria
- •Patient deemed unfit for enrollment by the documented opinion of the investigator
- •Watch and wait patients
- •Richter's transformation
- •Patients otherwise not eligible for (pharmacological) intervention
- •Moribund patients
Outcomes
Primary Outcomes
Proportion of patients on different types of pharmacological regimen for treatment of Chronic Lymphocytic Leukaemia (CLL) or Indolent Non Hodgkin's Lymphoma (iNHL)
Time Frame: Baseline, 1 year and 2 years after baseline (up to 30 months)
Types of combination treatment (including but not limited to R-CHOP \[rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone\] , FCR \[fludarabine, cyclophosphamide, rituximab\], COP \[cyclophosphamide, doxorubicin, prednisone\], BR \[bendamustine, rituximab\], etc.) will be collected in treatment-naïve and relapsed patients. Data to be described as percentage of patients on each regimen.
Secondary Outcomes
- CLL specific variable: Clinically relevant biomarker status(up to 30 months)
- Safety as assessed by adverse events(up to 30 months)
- CLL specific variable: Histology(up to 30 months)
- Number of subjects in complete remission(up to 30 months)
- Number of subjects in partial remission(up to 30 months)
- Duration of response(up to 30 months)
- Overall survival(up to 30 months)
- iNHL specific variables: Histology(up to 30 months)
- CLL specific variable: Rai/Binet staging systems(up to 30 months)
- iNHL specific variables: Clinically relevant biomarker status(up to 30 months)
- Progression free survival(up to 30 months)
- Disease type and staging(up to 30 months)
- Clinical responses(up to 30 months)
- Health-related quality of life variables(up to 30 months)
- iNHL specific variables: Ann Arbor staging classification(up to 30 months)