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

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ClinicalTrials.gov Identifier: NCT02273856
Recruitment Status : Terminated (The study was terminated due to insufficient subject enrollment and very slow enrollment.)
First Posted : October 24, 2014
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma International B.V. )

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
Indolent Non Hodgkin's Lymphoma (iNHL) Chronic Lymphocytic Leukaemia (CLL)

Detailed Description:
Patients will be followed up to 30 months.

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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 : January 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Duration of response [ Time Frame: up to 30 months ]
  2. Overall survival [ Time Frame: up to 30 months ]
  3. Progression free survival [ Time Frame: up to 30 months ]
  4. Number of subjects in complete remission [ Time Frame: up to 30 months ]
  5. Number of subjects in partial remission [ Time Frame: up to 30 months ]
  6. Disease type and staging [ Time Frame: up to 30 months ]
  7. Clinical responses [ Time Frame: up to 30 months ]
    Relapses, response or non-response to treatment

  8. Safety as assessed by adverse events [ Time Frame: up to 30 months ]
  9. 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.

  10. 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.

  11. 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

  12. CLL specific variable: Rai/Binet staging systems [ Time Frame: up to 30 months ]
    Percentage of patients in the different stages.

  13. 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.

  14. iNHL specific variables: Ann Arbor staging classification [ Time Frame: up to 30 months ]
    Percentage of patients in the different stages.

  15. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273856


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

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Responsible Party: Astellas Pharma International B.V.
ClinicalTrials.gov Identifier: NCT02273856    
Other Study ID Numbers: ONC-MA-1002
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: May 2016
Keywords provided by Astellas Pharma Inc ( Astellas Pharma International B.V. ):
Chronic Lymphocytic Leukaemia (CLL)
Indolent Non Hodgkin's Lymphoma (iNHL)
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell