Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Lymphocytic Leukemia
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: B Cell Chronic Lymphocytic Leukemia
Intervention: alemtuzumab (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Genzyme, a Sanofi Company Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Campath vs. chlorambucil
Secondary outcome: survival comparison
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Ft. Myers, Florida, United States
Tampa, Florida, United States
Hines, Illinois, United States
Louisville, Kentucky, United States
Paducah, Kentucky, United States
Lafayette, Louisiana, United States
Jackson, Mississippi, United States
Tupelo, Mississippi, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
Billings, Montana, United States
Omaha, Nebraska, United States
New Hyde Park, New York, United States
Rochester, New York, United States
Durham, North Carolina, United States
Sioux Falls, South Dakota, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Additional Information
Link to Results Synopsis for CAM307
Starting date: July 2001
Last updated: February 4, 2014
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