Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00824265

Purpose

The purpose of this study is to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia	Drug: OFC Infusion Drug: FC infusion	Phase III

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

Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Ofatumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects With Relapsed Chronic Lymphocytic Leukemia

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Progression-free-survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical benefit, safety, tolerability, changes in patient reported outcome measures and pharmacokinetics. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	352
Study Start Date:	March 2009
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fludarabine, Cyclophosphamide: Active Comparator	Drug: FC infusion Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 cycles
Ofatumumab, Fludarabine, Cyclophosphamide: Experimental	Drug: OFC Infusion Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles

Detailed Description:

Fludarabine is currently approved for treatment of relapsed Chronic Lymphocytic Leukemia. Studies have shown that drugs in combination with fludarabine have shown more effectiveness than fludarabine alone. The addition of ofatumumab to fludarabine-cyclophosphamide combination offers potentially a more effective therapy, without additional toxicity.

The objective of this study is to determine the effect of ofatumumab added to fludarabine and cyclophosphamide in patients with Chronic Lymphocytic Leukemia who have responded previously to therapy but later develop progressive disease and require additional therapy.

Eligibility

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

Criteria

Inclusion Criteria:

confirmed and active CLL requiring treatment
at least one previous treatment for CLL and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression
fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
age 18yrs or older
signed written informed consent

Exclusion Criteria:

diagnosis of refractory CLL (failure to achieve a complete or partial remission/response or disease progression within 6 months of last anti-CLL treatment
abnormal/inadequate blood values, liver and kidney function
certain heart problems, serious significant diseases, AIHA, other current cancers or within the last 5 years
active or chronic infections
use of drugs to suppress allergic or inflammatory responses (glucocorticoids)
CLL transformation
CLL central nervous system involvement
current participation in other clinical study
inability to comply with the protocol activities
lactating or pregnant women or female patients of child-bearing potential (or male patinets with such partners) not willing to use adequate contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824265

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 118 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110913
Study First Received:	January 15, 2009
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00824265 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Relapsed
Ofatumumab
Oncology
Safety
Efficacy

Study placed in the following topic categories:

Antimetabolites
Leukemia, Lymphoid
Immunoproliferative Disorders
Immunologic Factors
Cyclophosphamide
Fludarabine monophosphate
Immunosuppressive Agents
Leukemia
Lymphatic Diseases

Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Antineoplastic Agents, Alkylating
Fludarabine
Antirheumatic Agents
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Alkylating Agents

Additional relevant MeSH terms:

Antimetabolites
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Alkylating Agents
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Fludarabine monophosphate
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Myeloablative Agonists
Fludarabine
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Leukemia, B-Cell
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009