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Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)

Phase 2
18 Years
Not Enrolling
Leukemia, Lymphocytic, Chronic, B-Cell

Thank you

Trial Information

Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)

As of April, 2011 Bayer transferred this record to Genzyme. Genzyme is now the sponsor of
this trial. NOTE: This study has previously been posted by Berlex, Inc. Berlex, Inc. has
been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Inclusion Criteria:

- Patient must have confirmed B-CLL.

- Patients must have received at least one prior therapy and must require treatment for
active disease

Exclusion Criteria:

- Treatment with any anti-cancer agents (chemotherapies, monoclonal antibodies, etc)
within 4 weeks of start of study.

- History of significant allergic reaction to antibody therapies that required
discontinuation of antibody therapy

- History of human immunodeficiency virus (HIV) positivity.

- Active infection requiring treatment

- Pregnancy or lactation

- Other severe, concurrent diseases or mental disorders

- Central nervous system involvement of chronic lymphocytic leukemia (CLL)

Type of Study:


Study Design:

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

Outcome Measure:

Complete Response (CR)

Outcome Description:

Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes <30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.

Outcome Time Frame:

28 days after last cycle with confirmation 2 months later

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

April 2008

Related Keywords:

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



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