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

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00801060

Purpose

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.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia (CLL)	Drug: Lumiliximab + FCR Drug: FCR	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Rituximab Lumiliximab

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL. [ Time Frame: June 2010 ] [ Designated as safety issue: Yes ]
To evaluate the efficacy of FCR+L compared with FCR alone in subjects with previously untreated CLL. [ Time Frame: June 2010 ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	February 2008
Study Completion Date:	September 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment Group A FCR + Lumiliximab (L) L (Lumiliximab): Day 2 50 mg/m2, Day 4 450 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks. F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks	Drug: Lumiliximab + FCR Dose, schedule, and duration in the protocol
Active Comparator: Treatment Group B FCR F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks	Drug: FCR Dosage, schedule, and duration in the protocol

Arms

Assigned Interventions

Experimental: Treatment Group A

FCR + Lumiliximab (L)

L (Lumiliximab): Day 2 50 mg/m2, Day 4 450 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks.

F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks

C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks

R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks

Drug: Lumiliximab + FCR

Dose, schedule, and duration in the protocol

Active Comparator: Treatment Group B

FCR

F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks

C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks

R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks

Drug: FCR

Dosage, schedule, and duration in the protocol

Detailed Description:

See protocol.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801060

Show 36 Study Locations

Sponsors and Collaborators

Biogen Idec

More Information

No publications provided

Responsible Party:	Study MD, Biogen Idec
ClinicalTrials.gov Identifier:	NCT00801060 History of Changes
Other Study ID Numbers:	152CL202, EUDRACT NO: 2008-002204-25
Study First Received:	December 2, 2008
Last Updated:	April 14, 2011
Health Authority:	Canada: Ethics Review Committee; Belgium: Federal Agency for Medicinal Products and Health Products; France: Ministry of Health; Austria: Federal Office for Safety in Health Care; France: Afssaps - French Health Products Safety Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; United States: Federal Government; Canada: Ministry of Health & Long Term Care, Ontario; France: Haute Autorité de Santé Transparency Commission; Austria: Ethikkommission; France: Institutional Ethical Committee; Australia: Department of Health and Ageing Therapeutic Goods Administration; France: French Data Protection Authority; Canada: Canadian Institutes of Health Research; Austria: Agency for Health and Food Safety; Poland: Ministry of Science and Higher Education; United Kingdom: Research Ethics Committee; Australia: National Health and Medical Research Council; Poland: Ministry of Health; Belgium: Ministry of Social Affairs, Public Health and the Environment; United Kingdom: National Health Service; Belgium: Institutional Review Board; France: National Consultative Ethics Committee for Health and Life Sciences; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Australia: Human Research Ethics Committee; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Food Standards Agency; United States: Food and Drug Administration; United Kingdom: Department of Health; Belgium: Directorate general for the protection of Public health: Medicines; France: Direction Générale de la Santé; Austria: Federal Ministry for Health and Women

Keywords provided by Biogen Idec:

Fludara
CD23
Cyclophosphamide
Antibody
Fludarabine
CLL
Rituximab

Mabthera
Biogen Idec
Lumiliximab
Rituxan
Cytoxan
Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine monophosphate
Rituximab
Fludarabine

Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on February 09, 2012