Clinical Trial: Fludara plus Alemtuzumab (Campath, MabCampath) vs Fludara alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) patients


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Sponsored by:	ILEX Pharmaceuticals
Information provided by:	ILEX Oncology

Condition	Treatment or Intervention	Phase
B-Cell Lymphocytic Leukemia	Drug: Alemtuzumab (Campath, MabCampath)	Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Safety/Efficacy Study

Official Title: Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy with Fludara plus Alemtuzumab (Campath, MabCampath) versus Fludara Alone in Patients with B-Cell Chronic Lymphocytic Leukemia

Inclusion Criteria:

A diagnosis of B-CLL; according to the NCI WG Criteria.
Relapsed or refractory disease after 1 prior regimen except patients who were refractory to (i.e., progressed on) Fludara or CAMPATH therapy. Patients who previously responded (CR or PR) to Fludara or CAMPATH therapy, but who have relapsed at the time of study entry, may be eligible but response to Fludara or CAMPATH therapy must have lasted >12 months (i.e., >12 months from a documented response to a documented relapse).
Binet stage A, stage B, or stage C or Rai Stage I through IV disease with evidence of progression as evidenced by the presence of one or more of the following: *Disease-related B symptoms (fever of greater than 38C [100.5F] for greater than or equal to 2 weeks without evidence of infection, night sweats without evidence of infection, weight loss >10%). *Evidence of progressive marrow failure as manifested by: 1) a decrease in hemoglobin to <11g/dL, or 2) a decrease in platelet count to <100 x 10^9/L within the previous 6 months, or 3) a decrease in absoluate neutrophil count (ANC) to <1.0 X 10^9/L. *Progressive splenomegaly to >2 cm below the left costal margin or other organomegaly. *Progressive lymphadenopathy. *Progressive lymphocytosis with an increase of 50% over a 2-month period, or an anticipated doubling time of less than 6 months.
World Health Organization (WHO) performance status(PS)of 0 or 1.
Life expectancy >12 weeks.
18 years of age or older.
Anti-cancer therapy, major surgery, or irradiation was completed >3 weeks before randomization in this study. Patient must have recovered from the acute side effects incurred as a result of previous therapy.
Serum creatinine greater than or equal to 2.0 x institutional upper limits of normal (ULN).
Adequate liver function as indicated by a total bilirubin, AST, and ALT greater than or equal to 2 x the institutional ULN value, unless directly attributable to the patient's tumor.
Female patients with childbearing potential must have a negative serum pregnancy test with 2 weeks of first dose of study drug(s). 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 following study therapy.
Signed, written informed consent (in the USA, includes HIPAA authorization).

Exclusion Criteria:

Previously treated with >1 prior regimen for B-CLL.
Previously treated with a fludarabine plus CAMPATH (FluCAM) regimen for B-CLL.
Positive Coombs test and actively hemolyzing. -ANC <1.5 x 10^9/L or platelet count <75 x 10^9/L, unless due to bone marrow involvement.
Medical condition requiring chronic use of oral corticosteroids.
History of anaphylaxis following exposure to monoclonal antibodies.
Use of investigational agents within 6 weeks prior to study randomization.
Active infection or hisotry of severe infection (grade 4) within 3 months prior to study randomization.
Known to be human immunodefiiency virus (HIV) positive.
Autoimmune thrombocytopenia.
Active secondary maligancy.
Known central nervous system (CNS) involvement with B-CLL.
Other severe, concurrent diseases, including tuberculosis, mental disorders, serious cardiac functional capacity (Class III or IV as defined by the New York Heart Association Classification), severe diabetes, severe hypertension, pulmonary disease (chronic obstructive pulmonary disease [COPD] with hypoxemia), or major organ malfunction (liver, kidney) that could interfere with the patient's ability to participate in the study.
Pregnant or nursing women.
Patients that have progressed with more aggressive B-cell cancers such as Richter's syndrome.
Known to be postive with hepatitis B or hepatitis C.