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Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00046683
Recruitment Status : Completed
First Posted : October 2, 2002
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Description
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Brief Summary:
This is a Phase III, open-label, multicenter, randomized, comparative study of Campath versus chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia (B-CLL). Eligible patients must have previously untreated, Rai stage I-IV disease, and be experiencing progression of their B-CLL requiring treatment. Patients who meet all eligibility criteria may be randomized on a 1:1 basis to receive either Campath or chlorambucil. An estimated 284 patients (142 per treatment arm) from approximately 40 or more investigational sites will be randomized to one of the two treatment arms.

Condition or disease Intervention/treatment Phase
B Cell Chronic Lymphocytic Leukemia Drug: alemtuzumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2001
Actual Study Completion Date : June 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Campath vs. chlorambucil

Secondary Outcome Measures :
  1. survival comparison

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00046683


Locations
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United States, Arizona
Tucson, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, Florida
Ft. Myers, Florida, United States
Tampa, Florida, United States
United States, Illinois
Hines, Illinois, United States
United States, Kentucky
Louisville, Kentucky, United States
Paducah, Kentucky, United States
United States, Louisiana
Lafayette, Louisiana, United States
United States, Mississippi
Jackson, Mississippi, United States
Tupelo, Mississippi, United States
United States, Missouri
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
United States, Montana
Billings, Montana, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New York
New Hyde Park, New York, United States
Rochester, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, Texas
San Antonio, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Medical Monitor Genzyme, a Sanofi Company
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00046683     History of Changes
Other Study ID Numbers: CAM307
First Posted: October 2, 2002    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Adult acute leukemia
Adult chronic leukemia
Childhood leukemia
Campath
Alemtuzumab

Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Leukemia, B-Cell
Alemtuzumab
Chlorambucil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action