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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 has been completed.
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00301301
First received: March 9, 2006
Last updated: January 11, 2010
Last verified: January 2010

March 9, 2006
January 11, 2010
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Complete list of historical versions of study NCT00301301 on ClinicalTrials.gov Archive Site
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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)
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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.

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Observational
Time Perspective: Retrospective
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Non-Probability Sample

39 participants aged over 18 with histological diagnosid of diffuse large B cell lymphoma and written informed consent. Patients who have received Gemcitabine-cisplatin, methylprednisolone (GEM-P) as per standard unit guidelines with or without Rituximab for relapsed/refractory DLBCL.

Non-Hodgkins Lymphoma
  • Drug: Gemcitabine
  • Drug: Cisplatinum
  • Drug: Rituximab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00301301
2656
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Royal Marsden NHS Foundation Trust
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Principal Investigator: David Cunningham, FRCP Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP