Clinical trial · Observational
informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
NCT02582879CI-TRIAL-00059827informCLLcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patient with CLL/SLL
- description
- 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.
Primary outcomes (4)
- measure
- Summarize baseline characteristics of study population, among CLL patients in a real-world setting
- timeFrame
- up to 7 years
- description
- \- Summarize baseline characteristics of study participants
- measure
- Summarize treatment patterns among CLL patients in a real-world setting
- timeFrame
- up to 7 years
- description
- * Summarize number of participants on various initial and subsequent treatments * Summarize proportion of patients switching therapies at each follow up time point
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDHallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Dohner 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. PMID 18216293