A Prognostic Tool for Early Stage CLL

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Development of a Prognostic Tool for Predicting Prognosis in Early Stage Chronic Lymphocytic Leukemia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436524
• Other study ID #: IOSI-EMA-005
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2021
• Source: Oncology Institute of Southern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims at developing a model for the prediction of time to first treatment in chronic lymphocytic leukemia patients presenting with asymptomatic early stage disease

Description:

Already existing and coded health-related personal data will be retrospectively collected from the CLL databases of the Institute of Oncology Research and of the Division of Hematology of the University of Eastern Piedmont.

The adjusted association between exposure variables and time to first treatment will be estimated by Cox regression. This approach will provide the covariates independently associated with progression free survival that will be utilized in the development of a model to predict time to first treatment.

Model performance (c-index and net reclassification improvement) in discriminating patients who will eventually be treated vs patients who will not be eventually treated will be compared with that of already existing prognostic model that have been validated to predict overall survival but not time to first treatment in CLL (i.e. CLL-IPI, MDACC score, Barcelona-Brno score).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4933
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female adults 18 years or older

• Diagnosis of chronic lymphocytic leukemia

• Binet A stage at presentation

• No treatment need at presentation

• Availability of the baseline and follow-up annotations

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Maggiore della Carità	Novara

Sponsors (2)

Lead Sponsor	Collaborator
Oncology Institute of Southern Switzerland	Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Condoluci A, Terzi di Bergamo L, Langerbeins P, Hoechstetter MA, Herling CD, De Paoli L, Delgado J, Rabe KG, Gentile M, Doubek M, Mauro FR, Chiodin G, Mattsson M, Bahlo J, Cutrona G, Kotaskova J, Deambrogi C, Smedby KE, Spina V, Bruscaggin A, Wu W, Moia R — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discrimination capacity of the study model (per c-index)	Primary endpoint of the study model ability in discriminating patients who will be eventually treated vs patients who will not be eventually treated.; The discrimination capacity of the model will be assessed by calculating the c-index. This approach will allow to estimate the model accuracy and its capacity of discriminating outcome at the individual patient level. Model performance (net reclassification improvement) in discriminating patients who will be eventually treated vs patients who will not be eventually treated will be compared with that of already existing prognostic models that have been validated to predict overall survival but not time to first treatment in CLL (i.e. CLL-IPI, MDACC score, Barcelona-Brno score).	Time to first treatment: interval between diagnosis and first line therapy (event), death without treatment (censoring), or last follow up without treatment (censoring), up to 20 years