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

Study Overview
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Brief Summary
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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
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Patients will be followed up to 30 months.

Official Title
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Prospective Multicentre Observational Registry Of Treatments And Outcomes In Patients With Chronic Lymphocytic Leukaemia Or Indolent Non Hodgkin's Lymphoma

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment naïve patients with CLL<br> | |
| Treatment naïve patients with iNHL<br> | |
| Relapsed/refractory patients with CLL<br> | |
| Relapsed/refractory patients with iNHL<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 1 year and 2 years after baseline (up to 30 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response |  | up to 30 months | 
| Overall survival |  | up to 30 months | 
| Progression free survival |  | up to 30 months | 
| Number of subjects in complete remission |  | up to 30 months | 
| Number of subjects in partial remission |  | up to 30 months | 
| Disease type and staging |  | up to 30 months | 
| Clinical responses | Relapses, response or non-response to treatment | up to 30 months | 
| Safety as assessed by adverse events |  | 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. | up to 30 months | 
| iNHL specific variables: Histology | Proportion of different subtypes in iNHL will be presented. Data to be described as percentage. | 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 | up to 30 months | 
| CLL specific variable: Rai/Binet staging systems | Percentage of patients in the different stages. | 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. | up to 30 months | 
| iNHL specific variables: Ann Arbor staging classification | Percentage of patients in the different stages. | 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. | up to 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lymphocytic Leukaemia (CLL), Indolent Non Hodgkin's Lymphoma (iNHL)