An observational study in Indolent Non Hodgkin's Lymphoma (iNHL) and Chronic Lymphocytic Leukaemia (CLL), sponsored by Astellas Pharma International B.V.. Terminated at 8 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-21.
Sponsored by Astellas Pharma International B.V. · Observational
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.
Patients will be followed up to 30 months.
130 studies on the registry are indexed under Leukemia, B-Cell; 47 are open to participants now.
This study's enrollment of 25 is below the median of 240 across 12 observational studies indexed under Leukemia, B-Cell.
Browse Leukemia, B-Cell studies →This is the only study on the registry with Astellas Pharma International B.V. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients are from the MENA region, and will be selected from sites that are considered clinical centres of excellence in the region.
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Exclusion Criteria:
Proportion of patients on different types of pharmacological regimen for treatment of Chronic Lymphocytic Leukaemia (CLL) or Indolent Non Hodgkin's Lymphoma (iNHL)
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.
Time frame: Baseline, 1 year and 2 years after baseline (up to 30 months)
Duration of response
Time frame: up to 30 months
Overall survival
Time frame: up to 30 months
Progression free survival
Time frame: up to 30 months
Number of subjects in complete remission
Time frame: up to 30 months
Number of subjects in partial remission
Time frame: up to 30 months
Disease type and staging
Time frame: up to 30 months
Clinical responses
Relapses, response or non-response to treatment
Time frame: up to 30 months
Safety as assessed by adverse events
Time frame: up to 30 months
CLL specific variable: Histology
Proportion of different subtypes in CLL: (1) histologically indolent CLL (HIC), defined as morphologically typical CLL with no histologic features of progression or transformation such as increased large cells, large confluent proliferation centers, or high proliferation rate; (2) CLL with histological features of intermediate aggressiveness histologically aggressive CLL \[HAC\]) (3) Richter's syndrome. Data to be described as percentage.
Time frame: up to 30 months
iNHL specific variables: Histology
Proportion of different subtypes in iNHL will be presented. Data to be described as percentage.
Time frame: up to 30 months
Health-related quality of life variables
Using EQ-5D questionnaire, including a visual analog scale (dimensions): mobility, self-care, usual activities, pain/discomfort, anxiety/depression
Time frame: up to 30 months
CLL specific variable: Rai/Binet staging systems
Percentage of patients in the different stages.
Time frame: up to 30 months
CLL specific variable: Clinically relevant biomarker status
Includes immunoglobulin heavy chain variable (IgHV) status, ZAP-70 (70-kDa zeta-associated protein), receptor status (including CD20), cytogenetics (6q, 11q, 13q, and 17p deletion or monosomy, trisomy 12 ). Percentages will be presented for the clinically relevant biomarker status.
Time frame: up to 30 months
iNHL specific variables: Ann Arbor staging classification
Percentage of patients in the different stages.
Time frame: up to 30 months
iNHL specific variables: Clinically relevant biomarker status
Includes receptor status (including CD20). Percentages will be presented for the clinically relevant biomarker status.
Time frame: up to 30 months
This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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