A Retrospective Review of Gemcitabine, Methylprednisolone Cisplatin (GEM-P) With or Without Rituximab in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Non-Hodgkins Lymphoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301301
• Other study ID #: 2656
• Status: Completed
• Phase: N/A
• First received: March 9, 2006
• Last updated: January 11, 2010

Study information

• Verified date: January 2010
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

There has been considerable international /national interest in the GEM−P regimen for treatment of patients with relapsed/refractory 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 2003:Ng M, Waters J, Cunningham D et al, Br J Cancer 2005;92:1352−7), we have treated relapsed/refractory 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 refractory/relapsed 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a) Age over 18 b) Histological diagnosis of diffuse large B cell lymphoma c) Patients who have received Gemcitabine-cisplatin, methylprednisolone (GEM-P) as per standard unit guidelines with or without Rituximab for relapsed/refractory DLBCL.

d) Informed written consent

Exclusion Criteria:

• a) Medical or psychiatric conditions that compromise the patient's ability to give informed consent b) HIV positive or AIDS related lymphoma

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Non-Hodgkins Lymphoma

Intervention

Drug:
• Gemcitabine

• Cisplatinum

• Rituximab

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom,