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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Gruppo Italiano Studio Linfomi
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier:
NCT00917540
First received: May 8, 2009
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time to Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier: NCT00917540     History of Changes
Other Study ID Numbers: O-CLL1
Study First Received: May 8, 2009
Last Updated: April 5, 2013
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on October 29, 2014