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Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01081015
Recruitment Status : Active, not recruiting
First Posted : March 5, 2010
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017


Groups and Cohorts


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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

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


  Show 165 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Justin L Ricker, MD PhD Celgene Corporation
More Information

Publications:
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01081015     History of Changes
Other Study ID Numbers: Connect™ CLL
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Keywords provided by Celgene:
Chronic Lymphocytic Leukemia
CLL
disease registry
Connect™

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell