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

• ClinicalTrials.gov Identifier: NCT02582879
• Recruitment Status: Active, not recruiting
• First Posted: October 21, 2015
• Last Update Posted: November 23, 2020
• Sponsor: Pharmacyclics LLC.
• 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

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.

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

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