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NCT Number: NCT02582879

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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia (CLL) Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clearview Cancer Institute, Huntsville, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Pharmacyclics LLC.

Industry

Collaborators

  • Janssen, LP

Registry information

Acronym: informCLL

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2015
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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