Clinical trial NCT00917540: Prospective Collection of Biological Data of Prognostic Relevance in Patients With B-Cell Chronic Lymphocytic Leukemia
Official title: Prospective Collection of Biological Data of Prognostic Relevance in Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Lymphocytic Leukemia Stage A(0)
Chronic Lymphocytic Leukemia Stage A(I)
Chronic Lymphocytic Leukemia Stage A(II)
Lead sponsor: Gruppo Italiano Studio Linfomi
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously untreated Binet stage A B-CLL patients, who do not necessitate therapy according to NCI guidelines

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.

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.

Primary outcomes:
measure: Prospective validation of the prognostic potential of a score system based on the presence/absence of three risk factors (VH mutational status, Zap-70 and CD38 expression) on Progression Free Survival (PFS ).
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 6 months
measure: Time to Treatment
timeFrame: 6 months
measure: Overall Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Modena
country: Italy
facility: GISL Trial Office
Study officials:
affiliation: GISL
name: Fortunato Morabito, MD
role: STUDY_CHAIR
affiliation: GISL
name: Manlio Ferrarini, MD
role: STUDY_CHAIR
References:
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citation: Morabito F, Tripepi G, Vigna E, Bossio S, D'Arrigo G, Martino EA, Storino F, Recchia AG, Fronza G, Di Raimondo F, Colombo M, Fais F, Neri A, Cutrona G, Ferrarini M, Gentile M. Validation of the Alternative International Prognostic Score-E (AIPS-E): Analysis of Binet stage A chronic lymphocytic leukemia patients enrolled into the O-CLL1-GISL protocol. Eur J Haematol. 2021 Jun;106(6):831-835. doi: 10.1111/ejh.13614. Epub 2021 Apr 7.
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citation: 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.
citation: 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.