Multicentre Registry of Treatments and Outcomes in Patients With Chronic Lymphocytic Leukaemia (CLL) Or Indolent Non Hodgkin's Lymphoma (iNHL)
- Conditions
- Indolent Non Hodgkin's Lymphoma (iNHL)Chronic Lymphocytic Leukaemia (CLL)
- Registration Number
- NCT02273856
- Lead Sponsor
- Astellas Pharma International B.V.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
- Informed consent
- CLL patients or
- iNHL patients
- Clinical decision made to initiate or adapt treatment of CLL/iNHL("Need to treat")
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients on different types of pharmacological regimen for treatment of Chronic Lymphocytic Leukaemia (CLL) or Indolent Non Hodgkin's Lymphoma (iNHL) 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 Outcome Measures
Name Time Method CLL specific variable: Clinically relevant biomarker status up to 30 months 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.
Safety as assessed by adverse events up to 30 months CLL specific variable: Histology up to 30 months 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.
Duration of response up to 30 months Overall survival up to 30 months iNHL specific variables: Histology up to 30 months Proportion of different subtypes in iNHL will be presented. Data to be described as percentage.
CLL specific variable: Rai/Binet staging systems up to 30 months Percentage of patients in the different stages.
iNHL specific variables: Clinically relevant biomarker status up to 30 months Includes receptor status (including CD20). Percentages will be presented for the clinically relevant biomarker status.
Number of subjects in complete remission up to 30 months Number of subjects in partial remission 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 Relapses, response or non-response to treatment
Health-related quality of life variables up to 30 months Using EQ-5D questionnaire, including a visual analog scale (dimensions): mobility, self-care, usual activities, pain/discomfort, anxiety/depression
iNHL specific variables: Ann Arbor staging classification up to 30 months Percentage of patients in the different stages.
Trial Locations
- Locations (8)
Site KW96501 Kuwait Cancer Control Center
🇰🇼Shuwaikh, Kuwait
Site JO96201 King Abdullah University Hospital
🇯🇴Irbid, Jordan
Site Hammoud Hospital University Medical Center
🇱🇧Beirut, Lebanon
Site Hamad Medical Coorporation, National Center for Cancer Care and Research, Al Amal Hospital
🇶🇦Doha, Qatar
Site OM96801 Sultan Qaboos University Hospital
🇴🇲Muscat, Oman
Site Hotel Dieu De France
🇱🇧Beirut, Lebanon
Site SA96601 Aseer Central Hospital
🇸🇦Abha, Aseer, Saudi Arabia
Site AE97101 Sheikh Khalifa Medical City
🇦🇪Abu Dhabi, United Arab Emirates