A Retrospective Study of Toxicity and Outcome of High Dose Chemotherapy With Autologous Stem Cell Transplant in Patients With Non-Hodgkin Lymphoma (NHL).

Tracking Information
First Submitted Date	March 9, 2006
First Posted Date	March 10, 2006
Last Update Posted Date	January 12, 2010
Study Start Date	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00301288 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	A Retrospective Study of Toxicity and Outcome of High Dose Chemotherapy With Autologous Stem Cell Transplant in Patients With Non-Hodgkin Lymphoma (NHL).
Official Title	Not Provided
Brief Summary	Patients with aggressive Non−Hodgkin−lymphoma treated at first diagnosis with chemotherapy alone or combined chemo-radiotherapy can achieve high response rates. However, patients with relapsed lymphoma still have a poor prognosis. High dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) is the treatment of choice for these patients. An ASCT allows patients to receive much higher doses of chemotherapy than usual, to improve the chances of curing the disease. The high−dose of chemotherapy destroys the cells in the patients bone marrow and then the patients own cells from either the bone marrow or peripheral blood are used to rescue the patient from intensive treatment. High−dose chemotherapy with autologous stem cell (either bone marrow or peripheral blood) transplantation is used in the treatment of Intermediate/High grade NHL with poor risk disease and in second remission at the Royal Marsden Hospital. The purpose of the present analysis is to determine independent prognostic factors correlated with the long−term outcome of patients with NHL who received an ASCT between January 1991 and June 2005. 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 to participate in the study for retrospective case note review, after discussion with a study investigator and after receiving a study information sheet. The results of the analysis will be published in a peer−reviewed medical journal. This will include patients treated at the royal Marsden Hospital only.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	152 participants with Non-Hodgkin's Lymphoma who have received an autologous stem cell trandplant in the past and have written informed consent.
Condition	Non-Hodgkins Lymphoma
Intervention	Procedure: Autologous stem cell transplant
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Enrollment; (submitted: January 11, 2010)	152
Original Enrollment	Not Provided
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: - a) Age over 18 b) Patients with Non-Hodgkin's Lymphoma who have received an autologous stem cell transplant in the past. c) 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United Kingdom
Removed Location Countries
Administrative Information
NCT Number	NCT00301288
Other Study ID Numbers	2657
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor	Royal Marsden NHS Foundation Trust
Collaborators	Not Provided
Investigators	Principal Investigator: David Cunningham, FRCP Royal Marsden NHS Foundation Trust
PRS Account	Royal Marsden NHS Foundation Trust
Verification Date	January 2010