informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-005420
NCT ID: NCT02582879
Sponsor Protocol Number: PCYC-1134M-CA
About this study
The purpose of the InformCLL Registry is to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL /SLL therapies/regimens. This study also evaluates association of treatment patterns with patient characteristics, healthcare resource utilization and patient reported Health related Quality of Life (HRQoL).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age of at least 18 years.
- Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008).
- Initiating treatment within ±45 days of enrollment with novel therapies including oral kinase inhibitors (e.g., inhibitors of BTK [e.g., ibrutinib],inhibitors of BCL-2 pathway [ e.g venetoclax] or PI3K [e.g., idelalisib]), or with other anti-CLL therapies/regimens approved at the time of patient enrollment.
- Availability of documentation of previous CLL/SLL treatment and duration of response in the patient's medical records.
- 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.
Exclusion Criteria:
- Diagnosis of B-cell malignancies other than CLL/SLL.
- Estimated life expectancy <6 months.
- Currently receiving treatment in an interventional clinical trial with a non-approved, investigational agent for CLL/SLL at study entry (note: patients who enroll in an interventional clinical trial after enrollment may remain in the registry).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator Sikander Ailawadhi, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
-
Standardized criteria for diagnosis and response assessment are needed to interpret and compare clinical trials and for approval of new therapeutic agents by regulatory agencies. Therefore, a National Cancer Institute-sponsored Working Group (NCI-WG) on chronic lymphocytic leukemia (CLL) published guidelines for the design and conduct of clinical trials for patients with CLL in 1988, which were updated in 1996. During the past decade, considerable progress has been achieved in defining new prognostic markers, diagnostic parameters, and treatment options. This prompted the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) to provide updated recommendations for the management of CLL in clinical trials and general practice.
Read More on PubMed