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

Sponsor

Astellas Pharma International B.V. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02273856

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Indolent Non Hodgkin's Lymphoma (iNHL) Chronic Lymphocytic Leukaemia (CLL)

Detailed Description

Patients will be followed up to 30 months.

Study Design

Study Type:

Observational

Actual Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Treatment naïve patients with CLL
Treatment naïve patients with iNHL
Relapsed/refractory patients with CLL
Relapsed/refractory patients with iNHL

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 [up to 30 months]
Relapses, response or non-response to treatment
Safety as assessed by adverse events [up to 30 months]
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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