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

June 17, 2016 updated by: Astellas Pharma International B.V.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Patients will be followed up to 30 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: 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.
Baseline, 1 year and 2 years after baseline (up to 30 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of response
Time Frame: up to 30 months
up to 30 months
Overall survival
Time Frame: up to 30 months
up to 30 months
Progression free survival
Time Frame: up to 30 months
up to 30 months
Number of subjects in complete remission
Time Frame: up to 30 months
up to 30 months
Number of subjects in partial remission
Time Frame: up to 30 months
up to 30 months
Disease type and staging
Time Frame: up to 30 months
up to 30 months
Clinical responses
Time Frame: up to 30 months
Relapses, response or non-response to treatment
up to 30 months
Safety as assessed by adverse events
Time Frame: up to 30 months
up to 30 months
CLL specific variable: Histology
Time Frame: 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.
up to 30 months
iNHL specific variables: Histology
Time Frame: up to 30 months
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
Time Frame: up to 30 months
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
Time Frame: up to 30 months
Percentage of patients in the different stages.
up to 30 months
CLL specific variable: Clinically relevant biomarker status
Time Frame: 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.
up to 30 months
iNHL specific variables: Ann Arbor staging classification
Time Frame: up to 30 months
Percentage of patients in the different stages.
up to 30 months
iNHL specific variables: Clinically relevant biomarker status
Time Frame: up to 30 months
Includes receptor status (including CD20). Percentages will be presented for the clinically relevant biomarker status.
up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma International B.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Astellas Pharma International B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONC-MA-1002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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