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Avastin in Chronic Lymphocytic Leukemia: Proof of Concept


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

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Trial Information

Avastin in Chronic Lymphocytic Leukemia: Proof of Concept


Inclusion Criteria:



- male or female patients, >=18 years of age;

- B-chronic lymphocytic leukemia not yet requiring treatment;

- ECOG performance status 0-2;

- no previous treatment of CLL by chemotherapy, radiotherapy or immunotherapy;

- life expectancy >6 months.

Exclusion Criteria:

- CNS involvement by lymphoma or any evidence of spinal cord compression;

- CT scan based evidence of tumor invading major blood vessels;

- GI tract involvement by CLL;

- active viral, bacterial or fungal infection;

- uncontrolled hypertension, CVA/stroke (<=6 months prior to randomization), myocardial
infarction (<=6 months prior to randomization), unstable angina (>=NYHA Grade IV),
thrombosis within 6 months before enrollment, NYHA Grade II CHF or serious cardiac
arrhythmia requiring ongoing medication.

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:

Bone marrow response after 6 months of Avastin

Outcome Time Frame:

Week 12 and Week 24

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Austria: Federal Agency for Safety in Health Care

Study ID:

ML21206

NCT ID:

NCT00754650

Start Date:

September 2008

Completion Date:

December 2010

Related Keywords:

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

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