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A Study of Chlorambucil Plus MabThera as Induction Therapy Followed in Responders by Maintenance Therapy Versus Observation on Response Rate in Patients >=60 Years With Previously Untreated Chronic Lymphocytic Leukemia


Phase 2
60 Years
N/A
Not Enrolling
Both
Lymphocytic Leukemia, Chronic

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Trial Information

A Study of Chlorambucil Plus MabThera as Induction Therapy Followed in Responders by Maintenance Therapy Versus Observation on Response Rate in Patients >=60 Years With Previously Untreated Chronic Lymphocytic Leukemia


Inclusion Criteria:



- adult patients, >=60 years of age;

- CD20+ chronic lymphocytic leukemia (CLL);

- no previous treatment for CLL;

- ECOG performance status 0-1.

Exclusion Criteria:

- co-morbid conditions requiring long term use of systemic corticosteroids during study
treatment;

- history of severe cardiac disease;

- transformation to aggressive B-cell malignancy.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall tumor response at end of induction phase

Outcome Time Frame:

10 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Italy: Ministry of Health

Study ID:

ML21445

NCT ID:

NCT00738374

Start Date:

November 2008

Completion Date:

January 2013

Related Keywords:

  • Lymphocytic Leukemia, Chronic
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Chronic Disease

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