Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry - Full Text View

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT01081015

Purpose

The purpose of the Connect™ Chronic Lymphocytic Leukemia (CLL) Disease Registry is to explore the history and real world management of patients diagnosed with CLL, provide insight into the management of CLL, and evaluate the effectiveness of first, second and subsequent therapeutic strategies employed in both the community and academic settings.

Condition
Chronic Lymphocytic Leukemia

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Identify and summarize patterns in therapeutic regimens and patient outcomes [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
The primary objective is to 1) describe practice patterns of first line therapy regimens and subsequent therapeutic strategies in patients initiated on therapy for CLL, as well as initiated on second line and subsequent therapies, in the community and academic setting (2) Provide insight into therapeutic regimens and therapy sequence in clinical practice as they relate to clinical outcomes in patients initiated on first-line, second-line or subsequent therapies for CLL.

Secondary Outcome Measures:

Summarize Effectiveness of Treatment Regimens [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Describe any differences in effectiveness associated with treatment regimens, including first-line regimens and subsequent therapeutic strategies in patients actively treated for CLL
Health Related Quality of Life Measures Related to Therapeutic Regimens [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Describe the health-related quality of life of patients actively treated for CLL, and to explore the association of HRQoL with therapeutic regimens, sequences and clinical outcomes.

Estimated Enrollment:	1500
Study Start Date:	March 2010
Estimated Study Completion Date:	March 2018
Estimated Primary Completion Date:	March 2018 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

An adult population (>=18 years old) of both men and women who have chronic lymphocytic leukemia treated in either community or academic medical centers.

Criteria

Inclusion Criteria:

Clinical diagnosis with CLL
Clinical decision made to initiate first-line therapy, second-line therapy or subsequent line of therapy prior to enrollment into the ConnectTM CLL registry, but within 2 months of enrollment
Age≥18 years
Willing and able to provide signed informed consent
Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from caregivers and/or trained site personnel

Exclusion Criteria:

Participation in a clinical study in which study treatment is blinded
Patient condition is considered terminal (i.e.<6 months to live)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081015

Contacts

Contact: Janeen Doyle

18009314630

connectcll@celgene.com

Locations

United States, Florida
Thomas Niederman, MD	Recruiting
Boynton Beach, Florida, United States, 33435
United States, New Jersey
Charles Farber, MD	Recruiting
Morristown, New Jersey, United States, 07962

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Emile Youssef, MD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Janeen Doyle, Study Manager, Disease Registries, Celgene Corporation
ClinicalTrials.gov Identifier:	NCT01081015 History of Changes
Other Study ID Numbers:	Connect™ CLL
Study First Received:	March 4, 2010
Last Updated:	April 5, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Celgene Corporation:

Chronic Lymphocytic Leukemia
CLL
disease registry
Connect™

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms

Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012