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
N/A
Not Enrolling
Both
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:

Interventional

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:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

13603

NCT ID:

NCT00206726

Start Date:

May 2005

Completion Date:

April 2008

Related Keywords:

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

Name

Location
Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Albany, Georgia  31701
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Seattle, Washington  98195
Flint, Michigan  48532
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Baltimore, Maryland  21287
Boston, Massachusetts  
Eugene, Oregon  
Milwaukee, Wisconsin  
Lebanon, New Hampshire  
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Washington, District of Columbia  
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