NCT02273856

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
7 countries

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

June 21, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

September 2, 2014

Last Update Submit

June 17, 2016

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • 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

  • +10 more secondary outcomes

Study Arms (4)

Treatment naïve patients with CLL

Treatment naïve patients with iNHL

Relapsed/refractory patients with CLL

Relapsed/refractory patients with iNHL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Informed consent
  • CLL patients or
  • iNHL patients
  • Clinical decision made to initiate or adapt treatment of CLL/iNHL("Need to treat")

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Site JO96201 King Abdullah University Hospital

Irbid, Irbid Governorate, 22110, Jordan

Location

Site KW96501 Kuwait Cancer Control Center

Ash Shuwaykh, Shuwaikh, 70653, Kuwait

Location

Site Hammoud Hospital University Medical Center

Beirut, Beyrouth, 1600, Lebanon

Location

Site Hotel Dieu De France

Beirut, Beyrouth, 166830, Lebanon

Location

Site OM96801 Sultan Qaboos University Hospital

Muscat, Muḩāfaz̧at Masqaţ, 123, Oman

Location

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

Doha, Baladīyat ad Dawḩah, 3050, Qatar

Location

Site SA96601 Aseer Central Hospital

Abhā, 'Asir Region, 61421, Saudi Arabia

Location

Site AE97101 Sheikh Khalifa Medical City

Abu Dhabi, Abu Dhabi Emirate, 51900, United Arab Emirates

Location

MeSH Terms

Conditions

Leukemia, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Medical Director

    Astellas Pharma International B.V.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

October 24, 2014

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

June 21, 2016

Record last verified: 2016-05

Locations

LE(2)OM(1)QA(1)SA(1)AE(1)JO(1)KU(1)