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

NCT ID: NCT00301301

Last Updated: 2010-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Hodgkins Lymphoma

Study Design

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Study Time Perspective

RETROSPECTIVE

Interventions

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Gemcitabine

Intervention Type DRUG

Cisplatinum

Intervention Type DRUG

Rituximab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Principal Investigators

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David Cunningham, FRCP

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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Royal Marsden NHS trust

Sutton, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2656

Identifier Type: -

Identifier Source: org_study_id

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