A Prognostic Tool for Early Stage CLL

NCT03436524 | Completed

• 1 other identifier: IOSI-EMA-005
• Study Type: observational
• Target: 4,933
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Lymphocytic Leukemia

Keywords

Early stage CLL; Binet A; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Training cohort

Cohort of chronic lymphocytic leukemia patients at Binet A stage for the development of the risk stratification model

Validation cohorts

Cohorts of chronic lymphocytic leukemia patients at Binet A stage for the validation of the risk stratification model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with asymptomatic chronic lymphocytic leukemia at stage Binet A.

You may qualify if:

• 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

You may not qualify if:

• None.

Sponsors & Collaborators

• Oncology Institute of Southern Switzerland: lead
• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Maggiore della Carità

Novara, 28100, Italy

Location

Related 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, Bianchi E, Gerber B, Zucca E, Gillessen S, Ghielmini M, Cavalli F, Stussi G, Hess MA, Baumann TS, Neri A, Ferrarini M, Rosenquist R, Forconi F, Foa R, Pospisilova S, Morabito F, Stilgenbauer S, Dohner H, Parikh SA, Wierda WG, Montserrat E, Gaidano G, Hallek M, Rossi D. International prognostic score for asymptomatic early-stage chronic lymphocytic leukemia. Blood. 2020 May 21;135(21):1859-1869. doi: 10.1182/blood.2019003453.

  PMID: 32267500 RESULT

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Davide Rossi, MD, PhD

  Oncology Institute of Southern Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal investigator

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: March 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

IT (1)