Multicentre Registry of Treatments and Outcomes in Patients With Chronic Lymphocytic Leukaemia (CLL) Or Indolent Non Hodgkin's Lymphoma (iNHL)

Astellas Pharma International B.V.25 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Indolent Non Hodgkin's Lymphoma (iNHL)Chronic Lymphocytic Leukaemia (CLL)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Site JO96201 King Abdullah University Hospital

Irbid, Irbid Governorate, Jordan

Site KW96501 Kuwait Cancer Control Center

Ash Shuwaykh, Shuwaikh, Kuwait

Site Hammoud Hospital University Medical Center

Beirut, Beyrouth, Lebanon

Site Hotel Dieu De France

Beirut, Beyrouth, Lebanon

Site OM96801 Sultan Qaboos University Hospital

Muscat, Muḩāfaz̧at Masqaţ, Oman

Site Hamad Medical Coorporation, National Center for Cancer Care and Research, Al Amal Hospital

Doha, Baladīyat ad Dawḩah, Qatar

Site SA96601 Aseer Central Hospital

Abhā, 'Asir Region, Saudi Arabia

Site AE97101 Sheikh Khalifa Medical City

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

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)

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)

Secondary Outcomes

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