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

Sponsor
Royal Marsden NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT00301301
Collaborator
(none)
39
Enrollment
1
Location

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Time Perspective:
Retrospective

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. 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.
    1. Informed written consent
    Exclusion Criteria:
      1. Medical or psychiatric conditions that compromise the patient's ability to give informed consent b) HIV positive or AIDS related lymphoma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Marsden NHS trust Sutton Surrey United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Royal Marsden NHS Foundation Trust

    Investigators

    • Principal Investigator: David Cunningham, FRCP, Royal Marsden NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00301301
    Other Study ID Numbers:
    • 2656
    First Posted:
    Mar 10, 2006
    Last Update Posted:
    Jan 12, 2010
    Last Verified:
    Jan 1, 2010
    Additional relevant MeSH terms:
    Lymphoma
    Gemcitabine
    Rituximab
    Cisplatin

    Study Results

    No Results Posted as of Jan 12, 2010