Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients

Completed · Phase 3

Conditions studied: B-Cell Chronic Lymphocytic Leukemia

In brief

This is a Phase 3, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of fludarabine plus alemtuzumab versus fludarabine alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the informed consent document may be entered on the study.

Key facts

Study ID

NCT00086580

Run by

Genzyme, a Sanofi Company

People needed

335

Starts

2004-07-01

Expected to finish

2010-06-01

Last updated by the study team

2014-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of B-cell chronic lymphocytic leukemia (B-CLL); according to the National Cancer Institute Working Group (NCI WG) criteria.
• Relapsed or refractory disease after 1 prior regimen except patients who were refractory to (i.e., progressed on) fludarabine or alemtuzumab therapy. Patients who previously responded (complete response or partial response) to fludarabine or alemtuzumab therapy, but who have relapsed at the time of study entry, may be eligible but response to fludarabine or alemtuzumab 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:
• I. 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 absolute neutrophil count (ANC) to <1.0 X 10\^9/L.
• II. Progressive splenomegaly to >2 cm below the left costal margin or other organomegaly.
• III. Progressive lymphadenopathy.
• IV. 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.
• 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 less than or equal to 2.0 x institutional upper limits of normal (ULN) and calculated creatinine clearance (CrCl) greater than or equal to 30mL/min using the Cockroft and Gault formula.
• Adequate liver function as indicated by a total bilirubin, AST, and ALT less 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.

You may not qualify if…

• Previously treated with >1 prior regimen for B-CLL.
• Previously treated with a fludarabine plus alemtuzumab (FluCAM) regimen for B-CLL.
• Positive Coombs test and actively hemolyzing.
• Absolute neutrophil count (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 pharmacologic doses of oral corticosteroids, i.e. anything other than replacement dose levels.
• History of anaphylaxis following exposure to monoclonal antibodies.
• Use of investigational agents within 6 weeks prior to study randomization.
• Active infection or history of severe infection (grade 4) within 3 months prior to study randomization.
• Known to be human immunodeficiency virus (HIV) positive.
• Autoimmune thrombocytopenia.
• Active second malignancy.
• 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.
• Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive hepatitis B serologies without prior immunization.

Where it is running

• Florida Cancer Specialists — Fort Myers, Florida, United States
• Medizinische Universitatsklinik Graz — Graz, Austria
• Universitat Wien AKH, Innere Medizin I — Vienna, Austria
• University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski — Pleven, Bulgaria
• UMHAT St. Georgi, Hematology Clinic — Plovdiv, Bulgaria
• Multiprofile Hospital for Active Treatment "Alexandrovska" — Sofia, Bulgaria
• National Center for Heamtology and Transfusiology — Sofia, Bulgaria
• Multiprofile Hospital for Active Treatment, St. Marina — Varna, Bulgaria
• Cancer Care Manitoba — Winnipeg, Manitoba, Canada
• Hopital Notre-Dame du CHUM — Montreal, Quebec, Canada
• Clinical Hospital Center Rijeka, Department of Haematology — Rijeka, Croatia
• Clinical Hospital Merkur — Zagreb, Croatia
• University Hospital Dubrava — Zagreb, Croatia
• CHRU - Hopital Claude Huriez — Lille, France
• Charite-Universitatsmedizin Berlin Campus Benjamin-Franklin — Berlin, Germany
• Charite Universitatsklinikum der Humboldt-Universitat zu Berlin — Berlin, Germany
• Klinikum der Universitat zu Koln, Klinik 1 fur Innere Medizin — Cologne, Germany
• Robert-Bosch Krankenhaus GmbH — Stuttgart, Germany
• "Laikon" General Hospital, University of Athens — Goudi, Athens, Greece
• U.O. Oncologia Medica Azienda Ospedaliera "Pugliese-Ciaccio" — Cantanzaro, Italy
• Unita Operativa di Medicina Generale Reumatologia e Oncoematologia — Milan, Italy
• Istituto di Ematologia Dipartmento di Biotechnologie Celluari ed Ematologia, Universita di Roma "La Sapienza" — Rome, Italy
• Klinika Hematologii i Transplantacji Szpiku — Katowice, Poland
• Klinika Hematologii AM — Lodz, Poland
• Klinika Hematologii Pomorskiej Akademii Medycznej w Szczecinie — Szczecin, Poland

Full record on ClinicalTrials.gov

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