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Trial record 1 of 1 for:    CONNECT CLL
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Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01081015
First received: March 4, 2010
Last updated: December 31, 2013
Last verified: December 2013

March 4, 2010
December 31, 2013
September 2009
September 2017   (final data collection date for primary outcome measure)
  • Identify and summarize patterns in therapeutic regimens [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
    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
  • Clinical outcomes [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
    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.
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.
Complete list of historical versions of study NCT01081015 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry
Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Chronic Lymphocytic Leukemia
Not Provided
Not Provided
Pashos CL, Flowers CR, Kay NE, Weiss M, Lamanna N, Farber C, Lerner S, Sharman J, Grinblatt D, Flinn IW, Kozloff M, Swern AS, Street TK, Sullivan KA, Harding G, Khan ZM. Association of health-related quality of life with gender in patients with B-cell chronic lymphocytic leukemia. Support Care Cancer. 2013 Oct;21(10):2853-60. doi: 10.1007/s00520-013-1854-z. Epub 2013 Jun 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
September 2017
September 2017   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Kristen Sullivan 913-266-0329 connectcll@celgene.com
United States,   Puerto Rico
 
NCT01081015
Connect™ CLL
No
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Kenneth Foon, MD Celgene Corporation
Celgene Corporation
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP