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

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ClinicalTrials.gov Identifier: NCT00917540
Recruitment Status : Unknown
Verified April 2013 by Gruppo Italiano Studio Linfomi.
Recruitment status was:  Recruiting
First Posted : June 10, 2009
Last Update Posted : April 9, 2013
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Studio Linfomi

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.

Condition or disease
Chronic Lymphocytic Leukemia Stage A(0) Chronic Lymphocytic Leukemia Stage A(I) Chronic Lymphocytic Leukemia Stage A(II)

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.

Study Type : Observational
Estimated Enrollment : 495 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Collection of Biological Data of Prognostic Relevance in Patients
Study Start Date : February 2007
Estimated Study Completion Date : April 2013





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

Biospecimen Retention:   Samples With DNA
Peripheral blood


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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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917540


Contacts
Contact: Fortunato Morabito, MD +39 0984 681329 fortunato_morabito@tin.it

Locations
Italy
GISL Trial Office Recruiting
Modena, Italy, 41100
Contact: Emanuela A Pesce, BSc    +39 059 422 2688    emanuelaanna.pesce@unimore.it   
Principal Investigator: Massimo Federico, MD         
Sponsors and Collaborators
Gruppo Italiano Studio Linfomi
Investigators
Study Chair: Fortunato Morabito, MD GISL
Study Chair: Manlio Ferrarini, MD GISL

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier: NCT00917540     History of Changes
Other Study ID Numbers: O-CLL1
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: April 9, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell