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Prospective Collection of Biological Data of Prognostic Relevance in Patients

18 Years
80 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia Stage A(0), Chronic Lymphocytic Leukemia Stage A(I), Chronic Lymphocytic Leukemia Stage A(II)

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Trial Information

Prospective Collection of Biological Data of Prognostic Relevance in Patients

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.

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

- 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

- 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

- Age > 70 years.

- Without a written informed consent.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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 ).

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Fortunato Morabito, MD

Investigator Role:

Study Chair

Investigator Affiliation:



Italy: Ethics Committee

Study ID:




Start Date:

February 2007

Completion Date:

April 2013

Related Keywords:

  • Chronic Lymphocytic Leukemia Stage A(0)
  • Chronic Lymphocytic Leukemia Stage A(I)
  • Chronic Lymphocytic Leukemia Stage A(II)
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid