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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Gruppo Italiano Studio Linfomi.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Gruppo Italiano Studio Linfomi Identifier:
First received: May 8, 2009
Last updated: April 5, 2013
Last verified: April 2013
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Collection of Biological Data of Prognostic Relevance in Patients

Resource links provided by NLM:

Further study details as provided by Gruppo Italiano Studio Linfomi:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Quality of Life [ Time Frame: 6 months ]
  • Time to Treatment [ Time Frame: 6 months ]
  • Overall Survival [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Peripheral blood

Estimated Enrollment: 495
Study Start Date: February 2007
Estimated Study Completion Date: April 2013
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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00917540

Contact: Fortunato Morabito, MD +39 0984 681329

GISL Trial Office Recruiting
Modena, Italy, 41100
Contact: Emanuela A Pesce, BSc    +39 059 422 2688   
Principal Investigator: Massimo Federico, MD         
Sponsors and Collaborators
Gruppo Italiano Studio Linfomi
Study Chair: Fortunato Morabito, MD GISL
Study Chair: Manlio Ferrarini, MD GISL
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gruppo Italiano Studio Linfomi Identifier: NCT00917540     History of Changes
Other Study ID Numbers: O-CLL1
Study First Received: May 8, 2009
Last Updated: April 5, 2013

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell processed this record on July 19, 2017