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A Phase III Study to Evaluate the Efficacy and Safety of Front-Line Therapy With Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Chronic Lymphocytic Leukemia


Phase 3
18 Years
N/A
Not Enrolling
Both
B Cell Chronic Lymphocytic Leukemia

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Trial Information

A Phase III Study to Evaluate the Efficacy and Safety of Front-Line Therapy With Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Chronic Lymphocytic Leukemia


Inclusion Criteria:



- Histopathologically confirmed diagnosis of B-CLL with CD5, CD19, or CD23 positive
clone.

- Rai Stage I through IV disease with evidence of progression as evidenced by the
presence of one or more of the following:1. Disease-related B symptoms (fever of
greater than 38 celsius (100.5 F) for greater than or equal to 2 weeks without
evidence of infection, night sweats without evidence of infection, weight loss >10%
within previous 6 months. 2. Evidence of progression marrow failure as manifested by:
a. decrease in hemoglobin to <11g/dL or b. decrease in platelet count to <100x10 to
the ninth/L within the previous 6 months or c. decrease in absolute neutrophil count
(ANC) to <1.0x10 to the ninth/L within the previous 6 months. 3. Progressive
splenomegaly to >2 cm below the left costal margin or other organomegaly with
progressive increase over 2 consecutive clinic visits greater than or equal to 2
weeks apart. 4. Progressive lymphadenopathy with at least 5 sites of involvement with
either two nodes at least 2cm in longest diameter or one node greater than or equal
to 5cm in longest diameter with progressive increase over 2 consecutive visits
greater than or equal to weeks apart. 5. Progressive lymphocytes with an increase of
>50% over a 2-month period, or an anticipated doubling time of less than 6 months.

- Received no previous chemotherapy for B-CLL.

- Life expectancy of at least 12 weeks.

- WHO performance status of 0, 1, or 2.

- Serum creatinine less or equal to 2.0 times the institutional upper limit of normal
(ULN) value.

- Adequate liver function as indicated by a total bilirubin, AST, and ALT less or equal
to 2 times the institutional ULN value, unless directly attributable to the disease.

- Female patients with childbearing potential must have a negative serum pregnancy test
within 2 weeks prior to randomization. Male and female patients must agree to use an
effective contraceptive method while on study treatment, if appropriate, and for a
minimum of 6 months after study therapy.

- Signed, written informed consent.

- 18 years of age or older.

Exclusion Criteria:

- ANC less than 500 million per liter or platelet count less than 10 billion per liter.

- Medical condition requiring chronic use of oral corticosteroids.

- Autoimmune thrombocytopenia.

- Previous bone marrow transplant.

- Use of investigational agents within previous 30 days.

- Positive for HIV.

- Past history of anaphylaxis following exposure to rat or mouse-derived complementary
determining region (CDR) grafted humanized monoclonal antibodies.

- Active infection.

- Serious cardiac or pulmonary disease that could interfere with their ability to
participate in the study.

- Recent documented (with in 2 years) of active tuberculosis (TB), current active TB,
or currently receiving anti-tuberculosis medication.

- Active secondary malignancy.

- Central nervous system involvement with CLL.

- Positive quantitative CMV by PCR assay (using the laboratory normal ranges).

- A diagnosis of mantle cell lymphoma.

- Other severe, concurrent diseases or mental disorders.

- Pregnant or lactating women.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Campath vs. chlorambucil

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

CAM307

NCT ID:

NCT00046683

Start Date:

July 2001

Completion Date:

November 2006

Related Keywords:

  • B Cell Chronic Lymphocytic Leukemia
  • Adult acute leukemia
  • Adult chronic leukemia
  • Childhood leukemia
  • Campath
  • Alemtuzumab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, B-Cell
  • Leukemia, Lymphoid

Name

Location

Hinsdale, Illinois  60521
Great Falls, Montana  59405
Phoenix, Arizona  85012
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Austin, Texas  78705
Louisville, Kentucky  40207
McLean, Virginia  22101
Little Rock, Arkansas  72205-7199
Omaha, Nebraska  68114
Metairie, Louisiana  70006
Charlotte, North Carolina  
Jackson, Mississippi  
Sioux Falls, South Dakota