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

Completed

Conditions studied: Chronic Lymphocytic Leukemia (CLL)

In brief

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.

Key facts

Study ID

NCT02582879

Run by

Pharmacyclics LLC.

People needed

1504

Starts

2015-09-01

Expected to finish

2021-07-21

Last updated by the study team

2022-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwest Alabama Cancer Center, PC — Muscle Shoals, Alabama, United States
• Arizona Oncology Associates, PC - HAL — Glendale, Arizona, United States
• Arizona Oncology Associates, PC - HAL — Phoenix, Arizona, United States
• Arizona Oncology Associates, PC - HAL — Phoenix, Arizona, United States
• Arizona Oncology Associates, PC - HAL-Scottsdale — Tempe, Arizona, United States
• Mercy Research — Fort Smith, Arkansas, United States
• Genesis Cancer Center — Hot Springs, Arkansas, United States
• Clopton Clinic of Jonesboro, Inc. — Jonesboro, Arkansas, United States
• CARTI - Central Arkansas Radiation Therapy Institute — Little Rock, Arkansas, United States
• John Muir Health — Concord, California, United States
• North County Oncology Medical Clinic — Oceanside, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• St Joseph Heritage Healthcare — Santa Rosa, California, United States
• Sansum Clinic — Solvang, California, United States
• Gregory Smith, MD (Private Practice) — St. Helena, California, United States
• Solano Hematology Oncology — Vallejo, California, United States
• Rocky Mountain Cancer Centers, LLP- Aurora — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers, LLP- Boulder — Boulder, Colorado, United States
• Rocky Mountain Cancer Centers — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
• Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
• Rocky Mountain Cancer Centers, LLP- Lakewood — Lakewood, Colorado, United States
• Rocky Mountain Cancer Centers, LLP- Littleton — Littleton, Colorado, United States
• Rocky Mountain Cancer Centers, LLP- Sky Ridge — Lone Tree, Colorado, United States
• Clearview Cancer Institute — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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