Chronic Lymphocytic Leukaemia (CLL), Indolent Non Hodgkin's Lymphoma (iNHL)
Conditions
Keywords
Chronic Lymphocytic Leukaemia (CLL), Indolent Non Hodgkin's Lymphoma (iNHL)
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.
Interventions
None listed
Sponsors
Astellas Pharma International B.V.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 30 months | Relapses, response or non-response to treatment |
| Safety as assessed by adverse events | up to 30 months | — |
| Duration of response | 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. |
| 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 |
| CLL specific variable: Rai/Binet staging systems | up to 30 months | Percentage of patients in the different stages. |
| 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. |
| iNHL specific variables: Ann Arbor staging classification | 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. |
| 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. |
Countries
Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, United Arab Emirates
Outcome results
None listed