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Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry

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ClinicalTrials.gov Identifier: NCT01081015
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : May 12, 2020
Information provided by (Responsible Party):

Brief Summary:
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 or disease
Chronic Lymphocytic Leukemia

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Study Type : Observational
Actual Enrollment : 1494 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry
Actual Study Start Date : March 19, 2010
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Primary Outcome Measures :
  1. Identify and summarize patterns in therapeutic regimens and patient outcomes [ Time Frame: up to 8 years ]
    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 :
  1. Summarize Effectiveness of Treatment Regimens [ Time Frame: up to 8 years ]
    Describe any differences in effectiveness associated with treatment regimens, including first-line regimens and subsequent therapeutic strategies in patients actively treated for CLL

  2. Health Related Quality of Life Measures Related to Therapeutic Regimens [ Time Frame: up to 8 years ]
    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.

Information from the National Library of Medicine

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

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)

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): NCT01081015

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Sponsors and Collaborators
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Study Director: Kenneth Foon, MD Celgene Corporation
Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01081015    
Other Study ID Numbers: Connect™ CLL
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Keywords provided by Celgene:
Chronic Lymphocytic Leukemia
disease registry
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell