Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients - Full Text View

Sponsor:	GlaxoSmithKline
Collaborator:	Genmab
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00410163

Purpose

To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with chemotherapy in previously untreated patients with B-CLL

Condition	Intervention	Phase
B-cell Chronic Lymphocytic Leukemia	Drug: Ofatumumab	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Dose Comparison Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With Fludarabine and Cyclophosphamide, in Patients With Previously Untreated B-cell CLL

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Ofatumumab

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

• Complete Remissions measured from start of treatment until 3 months after last infusion [ Time Frame: 8 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of response, Time to next anti-CLL therapy, Reduction in tumor size, Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	56
Study Start Date:	November 2006
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Each patient will receive a total of 6 infusions with ofatumumab every 4 weeks in combination with fludarabine and cyclophosphamide. The first infusion will be 300mg followed by 5 infusions of 500mg	Drug: Ofatumumab ofatumumab 500mg or 1000mg should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 6½ hours.Infusions should be given every 4 weeks until a total of 6 infusions has been given.
2: Active Comparator Each patient will receive a total of 6 monthly infusions with ofatumumab in combination with fludarabine and cyclophosphamide. The first infusion will be 300mg followed by 5 infusions of 1000mg	Drug: Ofatumumab ofatumumab 500mg or 1000mg should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 6½ hours.Infusions should be given every 4 weeks until a total of 6 infusions has been given.

Eligibility

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

Criteria

Inclusion Criteria:

Patients with active B-CLL and with an indication for treatment
Age ≥ 18 years
Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out

Exclusion Criteria:

Any previous treatment for B-CLL or any other treatments that can be considered active against B-CLL
Glucocorticoid unless given in doses ≤ 10 mg /day for other indications than B-CLL (e.g. asthma)
Known transformation of B-CLL
Known CNS involvement of B-CLL
Past or current malignancy, except for:
1. Cervical carcinoma Stage 1B or less
2. Non-invasive basal cell and squamous cell skin carcinoma
3. Malignant melanoma with a complete response of a duration of > 10 years
4. Other cancer diagnoses with a complete response of a duration of > 5 years
Chronic or current infectious disease requiring systemic treatment
Clinically significant cardiac disease
Significant concurrent, uncontrolled medical condition
History of significant cerebrovascular disease
Known HIV positive
Positive serology for hepatitis B, unless due to vaccination
Leukapheresis, except as a safety measure before chemotherapy
ECOG Performance Status of 3 or 4
Patients who at the time of inclusion are not expected to be able to complete the ofatumumab-FC regimen
Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 1
Current participation in any other interventional clinical study
Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
Breast feeding women or women with a positive pregnancy test at Visit 1
Women of childbearing potential not willing to use adequate contraception for up to one year after last dose of ofatumumab. Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the USA the use of a double barrier method is also considered adequate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410163

Locations

United States, California
UCSD Cancer Center
La Jolla, California, United States, 92093
University of California LA Hematology, Oncology Center
Los Angeles, California, United States, 90095
United States, Illinois
Rusch Univeristy Medical Center
Chicago, Illinois, United States, 60612
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Texas
UTMD Anderson Cancer center, Dept. of Lukemia, Unit 428
Houston, Texas, United States, 77230-1402
Czech Republic
University Hospital Brno, Department of Hematooncology
Brno, Czech Republic
University Hospital Hradec Kralove, Department of Clinical Hematology
Hradec Kralove, Czech Republic
Okh Fnkv
Praha, Czech Republic
General Faculty Hospital
Praha, Czech Republic
Germany
Universitätsklinikum Essen
Essen, Germany, D-45122
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Klinikum der Universität zu Köln
Köln, Germany, D-50937
Johannes Gutenberg University, III. Medizinische Klinik
Mainz, Germany, D-55101
Hämatologie, Onkologie, Rheumatologie und Infektionskrankheiten, Universitätsklinikum Ulm
Ulm, Germany, 89081
Lithuania
Kanuas Medical University Hospital
Kaunas, Lithuania
Vilnius University Santariskiu Clinic
Vilnius, Lithuania

Sponsors and Collaborators

GlaxoSmithKline

Genmab

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
ClinicalTrials.gov Identifier:	NCT00410163 History of Changes
Other Study ID Numbers:	Hx-CD20-407
Study First Received:	December 11, 2006
Last Updated:	June 17, 2010
Health Authority:	United States: Food and Drug Administration; Germany: Paul-Ehrlich-Institut; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Lithuania: State Medicine Control Agency - Ministry of Health; Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:

B-cell, Chronic Lymphocytic Leukemia, Ofatumumab, fludarabine, cyclophosphamide

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
Fludarabine

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 September 01, 2010