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

NCT ID: NCT02273856

Last Updated: 2016-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Patients will be followed up to 30 months.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment naïve patients with CLL

No interventions assigned to this group

Treatment naïve patients with iNHL

No interventions assigned to this group

Relapsed/refractory patients with CLL

No interventions assigned to this group

Relapsed/refractory patients with iNHL

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma International B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma International B.V.

Locations

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Site JO96201 King Abdullah University Hospital

Irbid, Irbid Governorate, Jordan

Site Status

Site KW96501 Kuwait Cancer Control Center

Ash Shuwaykh, Shuwaikh, Kuwait

Site Status

Site Hammoud Hospital University Medical Center

Beirut, Beyrouth, Lebanon

Site Status

Site Hotel Dieu De France

Beirut, Beyrouth, Lebanon

Site Status

Site OM96801 Sultan Qaboos University Hospital

Muscat, Muḩāfaz̧at Masqaţ, Oman

Site Status

Site Hamad Medical Coorporation, National Center for Cancer Care and Research, Al Amal Hospital

Doha, Baladīyat ad Dawḩah, Qatar

Site Status

Site SA96601 Aseer Central Hospital

Abhā, 'Asir Region, Saudi Arabia

Site Status

Site AE97101 Sheikh Khalifa Medical City

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Site Status

Countries

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Jordan Kuwait Lebanon Oman Qatar Saudi Arabia United Arab Emirates

Other Identifiers

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ONC-MA-1002

Identifier Type: -

Identifier Source: org_study_id

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