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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)
This study is currently recruiting participants.
Verified by Royal Marsden NHS Foundation Trust, March 2006
First Received: March 9, 2006   Last Updated: October 12, 2006   History of Changes
Sponsored by: Royal Marsden NHS Foundation Trust
Information provided by: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00301301
  Purpose

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 retrosepective 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 Intervention
Non-Hodgkins Lymphoma
Drug: Gemcitabine
Drug: Cisplatinum
Drug: Rituximab

MedlinePlus related topics: Lymphoma
Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Rituximab
U.S. FDA Resources
Study Type: Observational
Study Design: Longitudinal, Defined Population, Retrospective Study
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301301

Contacts
Contact: Bhawna Sirohi, MBBS, MD 0044 208 661 3115 bhawna.sirohi@rmh.nhs.uk
Contact: Jacqui Oates 0044 2086613279 jacqui.oates@rmh.nhs.uk

Locations
United Kingdom, Surrey
Royal Marsden NHS trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Bhawna Sirohi, MBBS, MD     0044 208 661 3115     bhawna.sirohi@rmh.nhs.uk    
Sub-Investigator: Bhawna Sirohi, MBBs, MD            
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: David Cunningham, FRCP Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Study ID Numbers: 2656
Study First Received: March 9, 2006
Last Updated: October 12, 2006
ClinicalTrials.gov Identifier: NCT00301301     History of Changes
Health Authority: United Kingdom: National Health Service

Study placed in the following topic categories:
Antimetabolites
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Methylprednisolone
Immunosuppressive Agents
Antiviral Agents
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Radiation-Sensitizing Agents
Cisplatin
B-cell Lymphomas
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma, Large-cell
Gemcitabine
Lymphoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Lymphoma, B-Cell
Cisplatin
Therapeutic Uses
Gemcitabine
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Rituximab
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Radiation-Sensitizing Agents
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 07, 2009