Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163748
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2005-09-12
Brief Title:
Efficacy and Treatment Related Toxicity Study of a New Regimen for Lymphoma
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
A Pilot Study of Outpatient Vinorelbine and Gemcitabine With Filgrastim Support for Patients With Relapsed or Refractory Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-01
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:
This is an open label pilot study of 40 evaluable patients receiving vinorelbine-gemcitabine combination chemotherapy with filgrastim support in an outpatient setting Participating patients at the time of registration will have measurable relapsed or primary refractory lymphoma
Detailed Description:
Patients suffering from lymphoma a type of cancer of the white blood cells called lymphocytes have less chance of cure if they are refractory to initial chemotherapy or relapse after receiving initial chemotherapy when compared to patients who are responsive to and do not relapse following initial chemotherapy The standard of care therefore for these patients is to undergo some form of bone marrow transplant procedure However before this can be considered most patients require chemotherapy to control the lymphoma and to determine whether the lymphoma is still sensitive to alternative types of chemotherapy salvage chemotherapy Currently used types of salvage chemotherapy require significant periods of inpatient hospitalisation and are associated with significant haematological toxicities low blood counts with the associated risks of infection and bleeding and the need for blood and platelet transfusions Two new chemotherapy drugs vinorelbine and gemcitabine have both shown encouraging efficacy against lymphoma when used alone for patients with heavily pretreated lymphoma Furthermore they can be given in an outpatient setting and are usually not associated with significant haematological toxicity All the patients participating in this study have been diagnosed with relapsed or refractory lymphoma and have been offered treatment with vinorelbine and gemcitabine as an alternative to inpatient salvage chemotherapy
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