Ignite Creation Date:
2024-05-05 @ 11:56 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01453062
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2011-10-13
Brief Title:
Phase IV Observational Study in Chronic Lymphocytic Leukemia
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Phase IV Observational Study in Chronic Lymphocytic Leukemia Patients Receiving Ofatumumab in the European Union
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
B-cell chronic lymphocytic leukemia CLL is a subtype of mature peripheral B-cell neoplasms characterized by the accumulation of circulating malignant lymphocytes that typically express cell surface markers CD5 CD20 and CD23 It is the most common type of leukemia in adults in Western Europe and in the US The median age at diagnosis is 65-70 years with a male to female ratio of 21 Initially most patients present with asymptomatic lymphocytosis and do not need cytoreductive therapy Patients with active disease are characterized by a lymphocyte doubling time of less than 6 months or progressive even massive lymphadenopathy hepatosplenomegaly anemia and thrombocytopenia Constitutional symptoms such as fever night sweats unintended weight loss and extreme fatigue are common in advanced disease and can significantly impact quality of life CLL also causes relative immunosuppression that increases the risk of infections that are ultimately the major cause of death in this patient population Median survival at diagnosis ranges from 5 to 20 years depending on risk factors but is only 6 to 14 months for patients with CLL refractory to available therapies
Arzerra ofatumumab is a human monoclonal antibody IgG1 that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B-cell tumors
Arzerra is designated as an orphan medicinal product in the European Union EU for treatment of chronic lymphocytic leukemia The Committee for Orphan Medicinal Products COMP concluded that chronic lymphocytic leukemia was estimated to be affecting approximately 35 in 10000 persons in the Community at the time the application was made June 2008 and that the condition is chronically debilitating and life-threatening in particular due to poor long-term survival in high-risk patients
Arzerra was given a conditional approval in the EU on April 19 2010 The approved indication in the EU for the product is treatment of CLL in patients refractory to fludarabine and alemtuzumab A specific obligation for this conditional approval was an agreement by GSK to conduct a post-marketing observational study in CLL patients receiving Arzerra The data from this study is intended to enhance the evidence of the safety and efficacy of Arzerra as it is used in clinical practice and once final data are available together with results of a second specific obligation study will support the transition from conditional to a full approval of Arzerra in the EU
The objective of this observational study is to provide additional data to confirm the safety profile and efficacy of Arzerra for CLL patients treated in clinical practice
Particular data of interest are co-morbidities specific chronic disease diagnoses concomitant medications disease CLL characteristics prior treatment regimens adverse events reasons for discontinuation of Arzerra therapy Arzerra response progression free survival and overall survival
This is an observational non-interventional medical record review study in CLL patients A total of 100 patients with CLL who have previously received Arzerra whether alive or deceased and have either completed the full course of Arzerra therapy or discontinued treatment early will be eligible to participate in the study Centers across Europe who are members and non members of the European Research Initiative of CLL ERIC and treat CLL patients will participate in the study
CLL patients newly initiating Arzerra who are still undergoing the treatment phase and patients having been treated with Arzerra in phase II or phase III clinical trials will be excluded
For patients who have completed approximately 1 year or more of follow up since Arzerra initiation data on response to Arzerra adverse events during treatment and subsequent to treatment patient status progression free survival and overall survival covering the period up to approximately one-year post-drug initiation will be collected For patients who have not completed approximately l year of follow-up since Arzerra initiation including those who have been lost to follow up or died prior to one year or have not yet had a full year to elapse in calendar time similar data will be collected at the point in time at the last available patient contact with the physician using information in the record After approach for informed consent from the patient or next of kin for patients who have died to review the medical record no interaction with the patient will occur
Arzerra ofatumumab is a human monoclonal antibody IgG1 that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B-cell tumors
Arzerra is designated as an orphan medicinal product in the European Union EU for treatment of chronic lymphocytic leukemia The Committee for Orphan Medicinal Products COMP concluded that chronic lymphocytic leukemia was estimated to be affecting approximately 35 in 10000 persons in the Community at the time the application was made June 2008 and that the condition is chronically debilitating and life-threatening in particular due to poor long-term survival in high-risk patients
Arzerra was given a conditional approval in the EU on April 19 2010 The approved indication in the EU for the product is treatment of CLL in patients refractory to fludarabine and alemtuzumab A specific obligation for this conditional approval was an agreement by GSK to conduct a post-marketing observational study in CLL patients receiving Arzerra The data from this study is intended to enhance the evidence of the safety and efficacy of Arzerra as it is used in clinical practice and once final data are available together with results of a second specific obligation study will support the transition from conditional to a full approval of Arzerra in the EU
The objective of this observational study is to provide additional data to confirm the safety profile and efficacy of Arzerra for CLL patients treated in clinical practice
Particular data of interest are co-morbidities specific chronic disease diagnoses concomitant medications disease CLL characteristics prior treatment regimens adverse events reasons for discontinuation of Arzerra therapy Arzerra response progression free survival and overall survival
This is an observational non-interventional medical record review study in CLL patients A total of 100 patients with CLL who have previously received Arzerra whether alive or deceased and have either completed the full course of Arzerra therapy or discontinued treatment early will be eligible to participate in the study Centers across Europe who are members and non members of the European Research Initiative of CLL ERIC and treat CLL patients will participate in the study
CLL patients newly initiating Arzerra who are still undergoing the treatment phase and patients having been treated with Arzerra in phase II or phase III clinical trials will be excluded
For patients who have completed approximately 1 year or more of follow up since Arzerra initiation data on response to Arzerra adverse events during treatment and subsequent to treatment patient status progression free survival and overall survival covering the period up to approximately one-year post-drug initiation will be collected For patients who have not completed approximately l year of follow-up since Arzerra initiation including those who have been lost to follow up or died prior to one year or have not yet had a full year to elapse in calendar time similar data will be collected at the point in time at the last available patient contact with the physician using information in the record After approach for informed consent from the patient or next of kin for patients who have died to review the medical record no interaction with the patient will occur
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EPI40635 | OTHER | GSK | None |
| WEUSRTP4799 | OTHER | None | None |