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

Non-Hodgkins Lymphoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301288
• Other study ID #: 2657
• Status: Completed
• Phase: N/A
• First received: March 9, 2006
• Last updated: January 11, 2010

Study information

• Verified date: January 2010
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non-Hodgkins Lymphoma

Intervention

Procedure:
• Autologous stem cell transplant

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom,