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Status unknownNCT00917540Updated Apr 9, 2013

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

An observational study in Chronic Lymphocytic Leukemia Stage A(0), Chronic Lymphocytic Leukemia Stage A(I) and Chronic Lymphocytic Leukemia Stage A(II), sponsored by Gruppo Italiano Studio Linfomi. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-04-09.

Sponsored by Gruppo Italiano Studio Linfomi · Observational

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
495
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Chronic Lymphocytic Leukemia Stage A(0)
  • Chronic Lymphocytic Leukemia Stage A(I)
  • Chronic Lymphocytic Leukemia Stage A(II)
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In context

Leukemia

5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's planned enrollment of 495 is above the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Gruppo Italiano Studio Linfomi is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Previously untreated Binet stage A B-CLL patients, who do not necessitate therapy according to NCI guidelines

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
495 participants (estimated)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. 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 ).

    Time frame: 6 months

Secondary outcomes

  1. Quality of Life

    Time frame: 6 months

  2. Time to Treatment

    Time frame: 6 months

  3. Overall Survival

    Time frame: 3 years

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Study locations

1 of 1 sites recruiting
  • GISL Trial Office
    Modena, 41100, Italy
    Recruiting
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References and documents

Publications

  • Matis S, Grazia Recchia A, Colombo M, Cardillo M, Fabbi M, Todoerti K, Bossio S, Fabris S, Cancila V, Massara R, Reverberi D, Emionite L, Cilli M, Cerruti G, Salvi S, Bet P, Pigozzi S, Fiocca R, Ibatici A, Angelucci E, Gentile M, Monti P, Menichini P, Fronza G, Torricelli F, Ciarrocchi A, Neri A, Fais F, Tripodo C, Morabito F, Ferrarini M, Cutrona G. MiR-146b-5p regulates IL-23 receptor complex expression in chronic lymphocytic leukemia cells. Blood Adv. 2022 Oct 25;6(20):5593-5612. doi: 10.1182/bloodadvances.2021005726. PubMed 35819446 ↗
  • 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. PubMed 33662164 ↗
  • 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. PubMed 32735048 ↗
  • 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. PubMed 26038121 ↗
  • 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. PubMed 25786252 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00917540
Lead sponsor
Gruppo Italiano Studio Linfomi
Responsible party
Sponsor
First posted
Jun 10, 2009
Start date
Feb 2007
Completion
Apr 2013 (estimated)
Last update
Apr 9, 2013

Study contacts

Fortunato Morabito, MD
Contact
fortunato_morabito@tin.it
+39 0984 681329
Fortunato Morabito, MD
study chair · GISL
Manlio Ferrarini, MD
study chair · GISL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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