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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: B-Cell Chronic Lymphocytic Leukemia

Intervention: FluCAM [Fludara + Campath] (Biological); fludarabine phosphate (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

Summary

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.

Clinical Details

Official title: A Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy With Fludarabine Plus Alemtuzumab vs. Fludarabine Alone in Patients With B-Cell Chronic Lymphocytic Leukemia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment

Secondary outcome:

Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP)

Kaplan-Meier Estimates of Overall Survival Time

Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP)

Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP)

Kaplan-Meier Estimates for Time to Alternative Therapy

Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline

Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment

Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline

Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment

Summary of Participants With Adverse Experiences (AEs)

Mean Systemic Clearance (CL) of Fludarabine

Total Volume of Distribution (Vss) of Fludarabine

Area Under the Curve (AUC) of Fludarabine From (AUC 0-tau)

Maximum Plasma Concentration (Cmax) of Fludarabine

Participants With Minimal Residual Disease (MRD)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Locations and Contacts

Medizinische Universitatsklinik Graz, Graz 8036, Austria

Universitat Wien AKH, Innere Medizin I, Wien 1090, Austria

University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven 5800, Bulgaria

UMHAT St. Georgi, Hematology Clinic, Plovdiv 4000, Bulgaria

Multiprofile Hospital for Active Treatment "Alexandrovska", Sofia 1431, Bulgaria

National Center for Heamtology and Transfusiology, Sofia 1756, Bulgaria

Multiprofile Hospital for Active Treatment, St. Marina, Varna 9010, Bulgaria

Clinical Hospital Center Rijeka, Department of Haematology, Rijeka 51000, Croatia

Clinical Hospital Merkur, Zagreb 10000, Croatia

University Hospital Dubrava, Zagreb 10000, Croatia

CHRU - Hopital Claude Huriez, Lille, Cedex 59037, France

Charite Universitatsklinikum der Humboldt-Universitat zu Berlin, Berlin 13353, Germany

Charite-Universitatsmedizin Berlin Campus Benjamin-Franklin, Berlin 12203, Germany

Klinikum der Universitat zu Koln, Klinik 1 fur Innere Medizin, Koln 50924, Germany

Robert-Bosch Krankenhaus GmbH, Stuttgart 70376, Germany

U.O. Oncologia Medica Azienda Ospedaliera "Pugliese-Ciaccio", Cantanzaro 88100, Italy

Unita Operativa di Medicina Generale Reumatologia e Oncoematologia, Milano 20132, Italy

Istituto di Ematologia Dipartmento di Biotechnologie Celluari ed Ematologia, Universita di Roma "La Sapienza", Rome 00161, Italy

Klinika Hematologii i Transplantacji Szpiku, Katowice 40-027, Poland

Klinika Hematologii AM, Lodz 93-513, Poland

Klinika Hematologii Pomorskiej Akademii Medycznej w Szczecinie, Szczecin 71-252, Poland

Katedra i Klinika Hamatologii, Onkologii I Chorob Wewnetrznych AM, Warszawa 02-097, Poland

Klinika Hematologii, Nowotworow Krwii 1 Transplantacji Szpiku, Wroclaw 50-367, Poland

Hospital de Santa Maria Servico de Hematologia Clinica/Hospital de dia de Hematologia, Lisboa 1649-035, Portugal

Hospital de Sao Teotonio, Servico de Hematologia/Hosptial de Dia Oncologico, Viseu 3504-509, Portugal

Institutol Clinic Fundeni, Clinica Heamtologie, Bucharest 022328, Romania

State Healthcare Department "Sverdlovsk Regional Clinical Hospital #1",, Ekaterinburg, 620102, Russian Federation

GU "Main Military Clinical Hospital named after acad. N.N.Burdenko of MO of Russia", Haematology Centre 3, Moscow 105229, Russian Federation

GOUVPO "Saint-Petersburg State Medical University named after acad I.P.Pavlov of Roszdrav", Bone Marrow Transplantology Clinic, Saint-Petersburg 197089, Russian Federation

Saint-Petersburg GUZ "City Hospital #31" 3, Dynamo Prospect, Saint-Petersburg 197110, Russian Federation

University Hospital, Dept. of Hematology, Lund 221 85, Sweden

Orebro University Hospital, Dep. of Medicine, Orebro 701 85, Sweden

Universitetssjukhuset, Orebro 701 85, Sweden

Medicin kliniken/Hematologsektionen, Sundsvall 851 86, Sweden

Akademiska sjukhuset, Uppsala 751 85, Sweden

Cherkasskly Oncology Dispensary, Cherkasy 79044, Ukraine

City Clinical Hospital #4, Regional Hematology Center, Dnepropetrovsk 49102, Ukraine

Donetsk State Medical University, Donetsk 83045, Ukraine

Kharkov Regional Clinical Oncology Center, Department of Hematology, Kharkov 61070, Ukraine

Khmelnitskiy Regional Hospital, Hematology Department, Khmelnitskiy 29000, Ukraine

Institute of Hematology and Transfusiology AMS of Ukraine, City Clinical Hospital #9, Kiev 04112, Ukraine

Institute of Oncology AMS of Ukraine, Kiev 03022, Ukraine

Scientific Centre for Radiation Medicine AMS of Ukraine, Dept of Hematology and Transplantology, Kyiv 03115, Ukraine

Lviv National Medical University named Danilo Galytcky, Lviv 79044, Ukraine

"Laikon" General Hospital, University of Athens, Goudi, Athens 11527, Greece

Florida Cancer Specialists, Fort Myers, Florida 33916, United States

Cancer Care Manitoba, Winnipeg, Manitoba R3E 0V9, Canada

Hopital Notre-Dame du CHUM, Montreal, Quebec H2L 4M1, Canada

Additional Information

Starting date: July 2004
Last updated: February 10, 2014

Page last updated: August 20, 2015

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