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

NCT00917540 | Unknown

• 1 other identifier: O-CLL1
• Study Type: observational
• Target: 495
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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 ).

  6 months

Secondary Outcomes (3)

• Quality of Life

  6 months

• Time to Treatment

  6 months

• Overall Survival

  3 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Italiano Studio Linfomi: lead

Study Sites (1)

GISL Trial Office

Modena, 41100, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 35819446 DERIVED

• 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.

  PMID: 33662164 DERIVED

• 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.

  PMID: 32735048 DERIVED

• 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.

  PMID: 26038121 DERIVED

• 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.

  PMID: 25786252 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

Study Officials

• Fortunato Morabito, MD

  GISL

  STUDY CHAIR

• Manlio Ferrarini, MD

  GISL

  STUDY CHAIR

Central Study Contacts

Fortunato Morabito, MD

CONTACT

+39 0984 681329; fortunato_morabito@tin.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: June 10, 2009
• Study Start: February 1, 2007
• Study Completion: April 1, 2013
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

IT (1)