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

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Lymphocytic Leukaemia (CLL); Indolent Non Hodgkin's Lymphoma (iNHL)

Detailed Description

Patients will be followed up to 30 months.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan, 22110
    • Site JO96201 King Abdullah University Hospital
• Kuwait
  • Shuwaikh, Kuwait, 70653
    • Site KW96501 Kuwait Cancer Control Center
• Lebanon
  • Beirut, Lebanon, 1600
    • Site Hammoud Hospital University Medical Center
  • Beirut, Lebanon, 166830
    • Site Hotel Dieu De France
• Oman
  • Muscat, Oman, 123
    • Site OM96801 Sultan Qaboos University Hospital
• Qatar
  • Doha, Qatar, 3050
    • Site Hamad Medical Coorporation, National Center for Cancer Care and Research, Al Amal Hospital
• Saudi Arabia
  • Aseer
    • Abha, Aseer, Saudi Arabia, 61421
      • Site SA96601 Aseer Central Hospital
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 51900
    • Site AE97101 Sheikh Khalifa Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Treatment naïve patients with CLL
Treatment naïve patients with iNHL
Relapsed/refractory patients with CLL
Relapsed/refractory patients with iNHL

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Astellas Pharma International B.V.
• Investigators: Study Director: Medical Director, Astellas Pharma International B.V.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: October 22, 2014
• First Posted (ESTIMATE): October 24, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Chronic Lymphocytic Leukaemia (CLL); Indolent Non Hodgkin's Lymphoma (iNHL)
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: ONC-MA-1002