Prospective Collection of Biological Data of Prognostic Relevance in Patients With B-Cell Chronic Lymphocytic Leukemia

NCT ID: NCT00917540

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 495 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2013-04-30

Brief Summary

The purpose of the present study is to develop a biological prognostic index in patients with Binet stage A Chronic Lymphocytic Leukemia (CLL) who do not necessitate therapy according to NCI guidelines and to prospectively validate the proposed score system based on the absence/presence of 1, 2 or 3 unfavorable prognostic markers such as cluster of differentiation 38 (CD38) expression, Zap-70 expression and immunoglobulin heavy chain variable region (IgVH) configuration.

Detailed Description

Clinical data including information on disease localization and laboratory parameters will be collected at study entry, during follow up and at disease progression (or after 36 months after registration) Biological markers will be evaluated at centralized laboratory, at study entry and at time of disease progression (or after 24 months of follow-up for non progressed patients) Using the scoring system, patients can be separated into 3 risk groups: low-risk (score 0), intermediate-risk (score 1) and high-risk (score 2-3), with significantly different clinical courses.

Conditions

Chronic Lymphocytic Leukemia Stage A(0); Chronic Lymphocytic Leukemia Stage A(I); Chronic Lymphocytic Leukemia Stage A(II)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Established diagnosis of B-CLL by NCI criteria, performed by local haematologist. (Diagnosis will be confirmed by the biological review committee according to flow cytometry analysis (positive clusters of differentiation antigen 5 (CD5), 19 (CD19),23 (CD23)).
• Age > 18 years and < 70 years.
• Eastern Cooperative Oncology Group (ECOG)<=2.
• Binet stage A.
• Diagnosis performed within 12 months before inclusion in the study.
• Patients who do not necessitate therapy by NCI guidelines (watch and wait policy).
• Shipment of peripheral blood sample to centralized laboratory for biological assessment.
• Clinical data including baseline information on disease localization and laboratory parameters at staging and assurance of follow up updating for at least 3 years are requested.
• Written informed consent.

Exclusion Criteria

• Patients with CLL whose diagnosis exceed 12 months before registration.
• Patients with leukemic phase of lymphoproliferative disorders of B origin CD5- and/or CD23- according to flow cytometry analysis.
• Clinical Binet stage B or C.
• Patients who necessitate therapy according to NCI guide-lines (no watch and wait policy).
• Age > 70 years.
• Without a written informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Studio Linfomi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fortunato Morabito, MD

Role: STUDY_CHAIR

GISL

Manlio Ferrarini, MD

Role: STUDY_CHAIR

GISL

Locations

GISL Trial Office

Modena, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fortunato Morabito, MD

Role: CONTACT

fortunato_morabito@tin.it

+39 0984 681329

Facility Contacts

Emanuela A Pesce, BSc

Role: primary

emanuelaanna.pesce@unimore.it

+39 059 422 2688

References

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Reference Type: DERIVED

PMID: 35819446 (View on PubMed)

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Reference Type: DERIVED

PMID: 33662164 (View on PubMed)

Kreuzberger N, Damen JA, Trivella M, Estcourt LJ, Aldin A, Umlauff L, Vazquez-Montes MD, Wolff R, Moons KG, Monsef I, Foroutan F, Kreuzer KA, Skoetz N. Prognostic models for newly-diagnosed chronic lymphocytic leukaemia in adults: a systematic review and meta-analysis. Cochrane Database Syst Rev. 2020 Jul 31;7(7):CD012022. doi: 10.1002/14651858.CD012022.pub2.

Reference Type: DERIVED

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Morabito F, Cutrona G, Mosca L, D'Anca M, Matis S, Gentile M, Vigna E, Colombo M, Recchia AG, Bossio S, De Stefano L, Maura F, Manzoni M, Ilariucci F, Consoli U, Vincelli I, Musolino C, Cortelezzi A, Molica S, Ferrarini M, Neri A. Surrogate molecular markers for IGHV mutational status in chronic lymphocytic leukemia for predicting time to first treatment. Leuk Res. 2015 Aug;39(8):840-5. doi: 10.1016/j.leukres.2015.05.005. Epub 2015 May 19.

Reference Type: DERIVED

PMID: 26038121 (View on PubMed)

Maura F, Mosca L, Fabris S, Cutrona G, Matis S, Lionetti M, Agnelli L, Barbieri M, D'Anca M, Manzoni M, Colombo M, Massucco C, Reverberi D, Gentile M, Recchia AG, Bossio S, Ilariucci F, Musolino C, Di Raimondo F, Cortelezzi A, Morabito F, Ferrarini M, Neri A. Insulin growth factor 1 receptor expression is associated with NOTCH1 mutation, trisomy 12 and aggressive clinical course in chronic lymphocytic leukaemia. PLoS One. 2015 Mar 18;10(3):e0118801. doi: 10.1371/journal.pone.0118801. eCollection 2015.

Reference Type: DERIVED

PMID: 25786252 (View on PubMed)

Other Identifiers

O-CLL1

Identifier Type: -

Identifier Source: org_study_id