Status:
COMPLETED
Phase 2 Fludarabine, Cytoxan and FCCAM <Alemtuzumab> in Untreated B-Cell Chronic Lymphocytic Leukemia
Lead Sponsor:
Steven E. Coutre
Collaborating Sponsors:
Bayer
Conditions:
Leukemia
B-cell Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fluda...
Detailed Description
This single-arm study evaluated the safety and efficacy of the combination of fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC in previously untreated CLL patients. Participants received ...
Eligibility Criteria
Inclusion
- ≥ age 18
- Karnofsky performance status 60% or above
- Confirmed immunohistological diagnosis of Chronic Lymphocytic Leukemia (CLL)
- Rai Stage I to IV as follows:
- Advanced stage disease (Rai Stage III or IV, or modified Rai High Risk)
- OR
- Patients with Rai Stage I - II or (Modified Rai Intermediate-Risk) disease must have an indication for therapy based on 1996 NCI revised criteria for active disease as follows:
- Any one of the following disease-related symptoms:
- Weight loss ≥ 10% body weight within the previous 6 months
- Extreme fatigue
- Fever greater than 100.5° F for ≥ 2 weeks without evidence of infection
- Night sweats without evidence of infection
- Evidence of progressive marrow failure based on the development of worsening of anemia or thrombocytopenia
- Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy
- Massive (\> 6 cm below the left costal margin) or progressive splenomegaly
- Bulky (\>10 cm in cluster) or progressive lymphadenopathy
- Progressive lymphocytosis \> 50% increase over 2 months, or anticipated doubling time \< 6 months
- Patients with immunoglobulin VH gene in unmutated nucleotide sequence configuration, as defined by ≥ 98% homology with the nearest germline counterpart
- Serum creatinine ≤ 2x the upper limit of normal
- Total serum bilirubin ≤ 2x the upper limit of normal.
- AST ≤ 2x the upper limit of normal.
- ALT ≤ 2x the upper limit of normal.
- Signed written informed consent
Exclusion
- Prior pharmacological treatment for CLL
- Past history of anaphylaxis following exposure to monoclonal antibodies
- Active secondary malignancy or a history of malignant disease (other than CLL or non-melanoma skin cancer) within the preceding 5 years
- Any medical condition requiring systemic corticosteroids
- Active systemic infection
- Major systemic or other illness (including Coombs positivity and active hemolysis) that would, in the opinion of the investigator, interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results
- HIV positive by serologic testing
- Pregnant or nursing female
- Unwilling/unable to practice an acceptable form of contraception.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00230282
Start Date
July 1 2004
End Date
October 1 2011
Last Update
October 6 2014
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305