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Trial record 1 of 2 for:    connect cll
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Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081015
First Posted: March 5, 2010
Last Update Posted: September 12, 2017
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.
Information provided by (Responsible Party):
Celgene
  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:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • 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:
  • 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

  • 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.


Enrollment: 1494
Actual Study Start Date: March 19, 2010
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: March 4, 2010
First Posted: March 5, 2010
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