Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Combination With Lumiliximab Versus FCR Alone in Subjects With Previously Untreated Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00801060
• Other study ID #: 152CL202
• Secondary ID: EUDRACT NO: 2008
• Status: Terminated
• Phase: Phase 2
• First received: December 2, 2008
• Last updated: September 17, 2015
• Start date: February 2008
• Est. completion date: September 2010

Study information

• Verified date: April 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeBelgium: Federal Agency for Medicinal Products and Health ProductsFrance: Ministry of HealthAustria: Federal Office for Safety in Health CareFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentUnited States: Federal GovernmentCanada: Ministry of Health & Long Term Care, OntarioFrance: Haute Autorité de Santé Transparency CommissionAustria: EthikkommissionFrance: Institutional Ethical CommitteeAustralia: Department of Health and Ageing Therapeutic Goods AdministrationFrance: French Data Protection AuthorityCanada: Canadian Institutes of Health ResearchAustria: Agency for Health and Food SafetyPoland: Ministry of Science and Higher EducationPoland: National Medicines InstituteUnited Kingdom: Research Ethics CommitteeAustralia: National Health and Medical Research CouncilPoland: Ministry of HealthBelgium: Ministry of Social Affairs, Public Health and the EnvironmentUnited Kingdom: National Health ServiceBelgium: Institutional Review BoardFrance: National Consultative Ethics Committee for Health and Life SciencesAustralia: Human Research Ethics CommitteeCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Food Standards AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited States: Food and Drug AdministrationUnited Kingdom: Department of HealthBelgium: Federal Agency for Medicines and Health Products, FAMHPFrance: Direction Générale de la SantéAustria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2, randomized, open-label, multicenter study in subjects with previously untreated CLL. It is designed to evaluate safety and efficacy of fludarabine, cyclophosphamide, rituximab (FCR) and lumiliximab versus FCR alone.

Description:

See protocol.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

• Age 18 years or older.

• Previously untreated CD23+ and CD20+ B cell CLL.

• Life expectancy >6 months.

• Subjects with Rai Stage III or IV (Binet Stage C) or Rai Stage I or II (Binet Stage A or B) if determined to have active disease.

• World Health Organization (WHO) Performance Status =2.

• Normal ECG with QTc =450 msec for men and =460 msec for women. PR interval (Print) must be <240 msec and QRS complex <110 msec. T wave flattening and T wave inversion will be permitted.

• All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 12 months after their last dose of study treatment.

• Acceptable liver function at Screening.

• Acceptable hematologic status at Screening.

• Acceptable renal function at Screening.

• Subjects receiving any medication known to affect the QTc interval must discontinue the use of the medication or be on a stable dose of the medication for at least 3 months or 5 half-lives (whichever is longer) prior to Study Day 1, and continue (whenever possible) at the same dose throughout the study.

EXCLUSION CRITERIA:

• Any prior therapy for CLL.

• Known history or positive test result for human immunodeficiency virus.

• Known history of, or positive test result for Hepatitis C virus (test for Hepatitis C virus antibody) or Hepatitis B virus (test for Hepatitis B Surface Antigen and Hepatitis B Core Antibody) at Screening.

• Uncontrolled diabetes mellitus.

• Uncontrolled hypertension.

• Hypokalemia.

• Hypomagnesemia.

• New York Heart Association Class III or IV cardiac disease; myocardial infarction within the past 6 months prior to Study Day 1.

• Arrhythmia (other than sinus arrhythmia) within 30 days prior to Study Day 1.

• Evidence of active myocardial ischemia on ECG.

• Subjects with pacemakers.

• Transformation to aggressive B-cell malignancy.

• Secondary malignancy requiring active treatment.

• Any medical condition that would require long-term use (>1 month) of systemic corticosteroids during study treatment.

• Any serious nonmalignant disease or laboratory abnormality, which would confound the evaluation of adverse events (AEs).

• Active bacterial, viral, or fungal infections.

• Any known family history of long QT syndrome.

• Seizure disorders requiring anticonvulsant therapy.

• Severe chronic obstructive pulmonary disease with hypoxemia.

• Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1.

• Clinically active autoimmune disease.

• Presence of history of Coombs positive hemolytic anemia.

• Pregnant or currently breastfeeding at Screening.

• Prior exposure to lumiliximab or any other anti CD23 antibody.

• Subjects with known hypersensitivity to Chinese hamster ovary cell proteins, murine proteins, or any component of fludarabine, cyclophosphamide, rituximab, or the lumiliximab investigational treatment.

Study Design

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Lumiliximab + FCR
Dose, schedule, and duration in the protocol
• FCR
Dosage, schedule, and duration in the protocol

Locations

Country	Name	City	State
Australia	Research Site	Melbourne (Coburg)	Victoria
Australia	Research Site	Westmead	New South Wales
Austria	Research Site	Graz
Austria	Research Site	Wien
Austria	Research Site	Wien
Belgium	Research Site	Antwerpen
Belgium	Research Site	Brussels
Belgium	Research Site	Brussels
Belgium	Research Site	Leuven
Belgium	Research Site	Mont-Godinne
Belgium	Research Site	Roeselare
Belgium	Research Site	Wilrijk
Canada	Research Site	Ottawa	Ontario
France	Research Site	Lille
France	Research Site	Montpellier
France	Research Site	Paris	Cedex
France	Research Site	Pessac
France	Research Site	Pierre Benite	Cedex
France	Research Site	Strasbourg
France	Research Site	Tours
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Lodz
United Kingdom	Research Site	Bath, Avon
United Kingdom	Research Site	Exeter	Devon
United Kingdom	Research Site	London	England
United Kingdom	Research Site	Plymouth	Devon
United States	Research Site	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Research Site	Detroit	Michigan
United States	University of Florida/Pulmonary, Critical Care & Sleep Medicine	Gainesville	Florida
United States	Research Site	Hackensack	New Jersey
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Vanderbilt University Medical Center-IPF Program	Nashville	Tennessee
United States	Research Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  France,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL.		June 2010	Yes
Primary	To evaluate the efficacy of FCR+L compared with FCR alone in subjects with previously untreated CLL.		June 2010	No