Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Lymphocytic Leukemia
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
1 other identifier
interventional
284
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2001
Longer than P75 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 1, 2002
CompletedFirst Posted
Study publicly available on registry
October 2, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedJuly 28, 2016
July 1, 2016
October 1, 2002
July 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Campath vs. chlorambucil
Secondary Outcomes (1)
survival comparison
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- years of age or older.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Fort Myers, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Hines, Illinois, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Paducah, Kentucky, United States
Unknown Facility
Lafayette, Louisiana, United States
Unknown Facility
Jackson, Mississippi, United States
Unknown Facility
Tupelo, Mississippi, United States
Unknown Facility
Jefferson City, Missouri, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Billings, Montana, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
New Hyde Park, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Sioux Falls, South Dakota, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2002
First Posted
October 2, 2002
Study Start
July 1, 2001
Study Completion
June 1, 2006
Last Updated
July 28, 2016
Record last verified: 2016-07