Clinical trial NCT02273856: Multicentre Registry of Treatments and Outcomes in Patients With Chronic Lymphocytic Leukaemia (CLL) Or Indolent Non Hodgkin's Lymphoma (iNHL)
Official title: Prospective Multicentre Observational Registry Of Treatments And Outcomes In Patients With Chronic Lymphocytic Leukaemia Or Indolent Non Hodgkin's Lymphoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Indolent Non Hodgkin's Lymphoma (iNHL)
Chronic Lymphocytic Leukaemia (CLL)
Keywords: Chronic Lymphocytic Leukaemia (CLL)
Indolent Non Hodgkin's Lymphoma (iNHL)
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are from the MENA region, and will be selected from sites that are considered clinical centres of excellence in the region.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients on different types of pharmacological regimen for treatment of Chronic Lymphocytic Leukaemia (CLL) or Indolent Non Hodgkin's Lymphoma (iNHL)
timeFrame: Baseline, 1 year and 2 years after baseline (up to 30 months)
Secondary outcomes:
measure: Duration of response
timeFrame: up to 30 months
measure: Overall survival
timeFrame: up to 30 months
measure: Progression free survival
timeFrame: up to 30 months
measure: Number of subjects in complete remission
timeFrame: up to 30 months
measure: Number of subjects in partial remission
timeFrame: up to 30 months
measure: Disease type and staging
timeFrame: up to 30 months
measure: Clinical responses
timeFrame: up to 30 months
measure: Safety as assessed by adverse events
timeFrame: up to 30 months
measure: CLL specific variable: Histology
timeFrame: up to 30 months
measure: iNHL specific variables: Histology
timeFrame: up to 30 months
measure: Health-related quality of life variables
timeFrame: up to 30 months
measure: CLL specific variable: Rai/Binet staging systems
timeFrame: up to 30 months
measure: CLL specific variable: Clinically relevant biomarker status
timeFrame: up to 30 months
measure: iNHL specific variables: Ann Arbor staging classification
timeFrame: up to 30 months
measure: iNHL specific variables: Clinically relevant biomarker status
timeFrame: up to 30 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Site JO96201 King Abdullah University Hospital
city: Shuwaikh
country: Kuwait
facility: Site KW96501 Kuwait Cancer Control Center
city: Beirut
country: Lebanon
facility: Site Hammoud Hospital University Medical Center
city: Beirut
country: Lebanon
facility: Site Hotel Dieu De France
city: Muscat
country: Oman
facility: Site OM96801 Sultan Qaboos University Hospital
city: Doha
country: Qatar
facility: Site Hamad Medical Coorporation, National Center for Cancer Care and Research, Al Amal Hospital
city: Abha
country: Saudi Arabia
facility: Site SA96601 Aseer Central Hospital
state: Aseer
city: Abu Dhabi
country: United Arab Emirates
facility: Site AE97101 Sheikh Khalifa Medical City
Study officials:
affiliation: Astellas Pharma International B.V.
name: Medical Director
role: STUDY_DIRECTOR
References: