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informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia (informCLL)

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ClinicalTrials.gov Identifier: NCT02582879
Recruitment Status : Active, not recruiting
First Posted : October 21, 2015
Last Update Posted : November 23, 2020
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Pharmacyclics LLC.

Tracking Information
First Submitted Date September 8, 2015
First Posted Date October 21, 2015
Last Update Posted Date November 23, 2020
Study Start Date September 2015
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 14, 2019)
  • Summarize baseline characteristics of study population, among CLL patients in a real-world setting [ Time Frame: up to 7 years ]
    - Summarize baseline characteristics of study participants
  • Summarize treatment patterns among CLL patients in a real-world setting [ Time Frame: up to 7 years ]
    • Summarize number of participants on various initial and subsequent treatments
    • Summarize proportion of patients switching therapies at each follow up time point
  • Summarize clinical outcomes among CLL patients in a real-world setting [ Time Frame: up to 7 years ]
    - Measures of effectiveness used will include survival status, ECOG Health status, response assessments as evaluated by the investigator such as: complete response, partial response, stable disease, progressive disease
  • Summarize health care resource utilization among CLL patients in a real-world setting [ Time Frame: up to 7 years ]
    - Summarize health care resource utilization among study participants
Original Primary Outcome Measures
 (submitted: October 19, 2015)
  • Summarize baseline characteristics of study population, among CLL patients in a real-world setting [ Time Frame: up to 6 years ]
    - Summarize baseline characteristics of study participants
  • Summarize treatment patterns among CLL patients in a real-world setting [ Time Frame: up to 6 years ]
    • Summarize number of participants on various initial and subsequent treatments
    • Summarize proportion of patients switching therapies at each follow up time point
  • Summarize clinical outcomes among CLL patients in a real-world setting [ Time Frame: up to 6 years ]
    - Measures of effectiveness used will include survival status, ECOG Health status, response assessments as evaluated by the investigator such as: complete response, partial response, stable disease, progressive disease
  • Summarize health care resource utilization among CLL patients in a real-world setting [ Time Frame: up to 6 years ]
    - Summarize health care resource utilization among study participants
Change History
Current Secondary Outcome Measures
 (submitted: June 14, 2019)
  • Summarize non serious adverse events (AEs) that led to discontinuation/modification/interruption of therapy and all serious adverse events in CLL patients [ Time Frame: up to 7 years ]
    - Summarize frequencies and percentages of AEs, that led to discontinuation/modification/interruption of therapy or death in CLL patients
  • Summarize patient-reported HRQoL scores [ Time Frame: up to 7 years ]
    - Summarize HRQoL scores as measured by FACT-G and additional questions from other PRO instruments at baseline and each follow-up
Original Secondary Outcome Measures
 (submitted: October 19, 2015)
  • Summarize adverse events (AEs) that led to discontinuations/dose modification/interruption of therapy or death in CLL patients [ Time Frame: up to 6 years ]
    - Summarize frequencies and percentages of AEs, that led to discontinuation/dose modification/interruption of therapy or death in CLL patients
  • Summarize patient-reported HRQoL scores [ Time Frame: up to 6 years ]
    - Summarize HRQoL scores as measured by FACT-G and additional questions from other validated PRO instruments at baseline and each follow-up
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Official Title informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Brief Summary The study is designed as a multicenter, prospective, observational registry of CLL/SLL patients who are initiating approved oral kinase inhibitors, BCL-2 inhibitors or other approved anti-CLL therapies/regimens. The study will characterize treatment patterns and their association with patient characteristics, healthcare resource utilization, and clinical outcomes, as well as patient-reported outcome (PRO) measures.
Detailed Description This multicenter, prospective, observational registry of CLL patients is designed to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors and other approved anti-CLL therapies/ regimens. The registry will provide information on regimens used to treat first-line and later lines of CLL as well as the sequencing of treatment regimens. The registry will also evaluate the association of these treatment patterns with patient characteristics, healthcare resource utilization, and functional outcomes including patient-reported HRQoL. These data will provide information to physicians that may help guide clinical practice and appropriate use of therapies, and will also provide information on HRQoL and healthcare resource utilization that will be of interest to healthcare decision makers.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples With DNA
Description:
blood samples
Sampling Method Non-Probability Sample
Study Population The registry will aim to enroll approximately 1500 patients with CLL/SLL from a total of 200 sites in the US over a 45 month enrollment period. In order to best capture real-world treatment patterns, site recruitment will aim to include approximately 85% of sites from the community hematology-oncology setting.
Condition Chronic Lymphocytic Leukemia (CLL)
Intervention Not Provided
Study Groups/Cohorts Patient with CLL/SLL
Patients with CLL/SLL in a real-world setting initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL therapies/regimens.
Publications * Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Döhner H, Hillmen P, Keating MJ, Montserrat E, Rai KR, Kipps TJ; International Workshop on Chronic Lymphocytic Leukemia. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008 Jun 15;111(12):5446-56. doi: 10.1182/blood-2007-06-093906. Epub 2008 Jan 23. Erratum in: Blood. 2008 Dec 15;112(13):5259.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: December 19, 2019)
1504
Original Estimated Enrollment
 (submitted: October 19, 2015)
1500
Estimated Study Completion Date October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age of at least 18 years
  • Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008)
  • Initiating anti-CLL/SLL treatment regimen (excluding clinical trials) within ±45 days of enrollment
  • Availability of documentation of previous CLL/SLL treatment and duration of response in the patient's medical records if patient has received prior line(s) of treatment (i.e. NOT treatment naïve)
  • Willing and able to provide informed consent
  • Willing and able to complete PRO instrument
  • Willing and able to provide information on patient survey questionnaire
  • Willing and able to provide a blood sample at time of enrollment prior to receiving treatment, as possible

Exclusion Criteria:

  • Diagnosis of B-cell malignancies other than CLL/SLL
  • Estimated life expectancy <6 months
  • Currently receiving treatment in an interventional clinical trial at time of entry into this study * Note- Exceptions: 1) Patients may enroll in interventional clinical trials for indications other than CLL/SLL, 2) The interventional clinical trial treatment is not the treatment used for meeting Inclusion Criteria #2 (or "Index Treatment"), 3) Patients may enroll in an interventional clinical trial indicated for CLL/SLL as later line of treatment after discontinuing the Index Treatment
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  
 
Administrative Information
NCT Number NCT02582879
Other Study ID Numbers PCYC-1134M-CA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pharmacyclics LLC.
Study Sponsor Pharmacyclics LLC.
Collaborators Janssen, LP
Investigators
Study Director: Alex Young Pharmacyclics LLC.
PRS Account Pharmacyclics LLC.
Verification Date November 2020