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

- Campath vs. chlorambucil
- survival comparison

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

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
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 |
Study Director: | Medical Monitor | Genzyme, a Sanofi Company |
Responsible Party: | Genzyme, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00046683 |
Other Study ID Numbers: |
CAM307 |
First Posted: | October 2, 2002 Key Record Dates |
Last Update Posted: | July 28, 2016 |
Last Verified: | July 2016 |
Adult acute leukemia Adult chronic leukemia Childhood leukemia Campath Alemtuzumab |
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 Antineoplastic Agents, Immunological Antineoplastic Agents |