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

Chronic Lymphocytic Leukaemia (CLL) Clinical Trial

— NADIR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02273856
• Other study ID #: ONC-MA-1002
• Status: Terminated
• Phase: N/A
• First received: September 2, 2014
• Last updated: June 17, 2016
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: May 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Qatar: Supreme Council Of HealthLebanon: Ministry of Public HealthUnited Arab Emirates: Ministry of HealthOman: Ministry of Health in Sultanate of OmanKuwait: Ministry of HealthJordan: Jordanian Food and Drug AdministrationSaudi Arabia: Saudi Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

Patients will be followed up to 30 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukaemia (CLL)
• Indolent Non Hodgkin's Lymphoma (iNHL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Non-Hodgkin

Locations

Country	Name	City	State
Jordan	Site JO96201 King Abdullah University Hospital	Irbid
Kuwait	Site KW96501 Kuwait Cancer Control Center	Shuwaikh
Lebanon	Site Hammoud Hospital University Medical Center	Beirut
Lebanon	Site Hotel Dieu De France	Beirut
Oman	Site OM96801 Sultan Qaboos University Hospital	Muscat
Qatar	Site Hamad Medical Coorporation, National Center for Cancer Care and Research, Al Amal Hospital	Doha
Saudi Arabia	Site SA96601 Aseer Central Hospital	Abha	Aseer
United Arab Emirates	Site AE97101 Sheikh Khalifa Medical City	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma International B.V.

Countries where clinical trial is conducted

Jordan,  Kuwait,  Lebanon,  Oman,  Qatar,  Saudi Arabia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Duration of response		up to 30 months	No
Secondary	Overall survival		up to 30 months	No
Secondary	Progression free survival		up to 30 months	No
Secondary	Number of subjects in complete remission		up to 30 months	No
Secondary	Number of subjects in partial remission		up to 30 months	No
Secondary	Disease type and staging		up to 30 months	No
Secondary	Clinical responses	Relapses, response or non-response to treatment	up to 30 months	No
Secondary	Safety as assessed by adverse events		up to 30 months	No
Secondary	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	No
Secondary	iNHL specific variables: Histology	Proportion of different subtypes in iNHL will be presented. Data to be described as percentage.	up to 30 months	No
Secondary	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	No
Secondary	CLL specific variable: Rai/Binet staging systems	Percentage of patients in the different stages.	up to 30 months	No
Secondary	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	No
Secondary	iNHL specific variables: Ann Arbor staging classification	Percentage of patients in the different stages.	up to 30 months	No
Secondary	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	No