Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301301
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2006-03-09
Brief Title:
A Retrospective Review of Gemcitabine Methylprednisolone Cisplatin GEM-P With or Without Rituximab in Patients With RelapsedRefractory Diffuse Large B Cell Lymphoma DLBCL
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-01
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:
There has been considerable international national interest in the GEM-P regimen for treatment of patients with relapsedrefractory lymphoma Currently there is no accepted standard therapy for these patients Since the publication of our experience with this regimen Study with CCR ethics number 1857 closed to recruitment in July 2003Ng M Waters J Cunningham D et al Br J Cancer 2005921352-7 we have treated relapsedrefractory lymphoma patients with this regimen and would like to undertake a retrospective review of a sub-group of these patients with diffuse large B cell lymphoma DLBCL
Patients treated with GEM-P with or without Rituximab prior to March 2005 for refractoryrelapsed DLBCL will be included in the analysis Accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment
All patients accrued will give informed consent for retrospective case note review after discussion with a study investigator and after receiving a study information sheet All eligible patients identified from the pharmacy database and will be consented at the time of the next clinic appointment if they are agreeable for the retrospective case note review
Patients treated with GEM-P with or without Rituximab prior to March 2005 for refractoryrelapsed DLBCL will be included in the analysis Accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment
All patients accrued will give informed consent for retrospective case note review after discussion with a study investigator and after receiving a study information sheet All eligible patients identified from the pharmacy database and will be consented at the time of the next clinic appointment if they are agreeable for the retrospective case note review
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