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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 : Completed
First Posted : March 5, 2010
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date March 4, 2010
First Posted Date March 5, 2010
Last Update Posted Date May 12, 2020
Actual Study Start Date March 19, 2010
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 4, 2010)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 4, 2010)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry
Official Title Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Chronic Lymphocytic Leukemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 20, 2015)
1494
Original Estimated Enrollment
 (submitted: March 4, 2010)
1500
Actual Study Completion Date December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number NCT01081015
Other Study ID Numbers Connect™ CLL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Celgene
Study Sponsor Celgene
Collaborators Not Provided
Investigators
Study Director: Kenneth Foon, MD Celgene Corporation
PRS Account Celgene
Verification Date May 2020