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

Hodgkin Lymphoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301314
• Other study ID #: 2655
• 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

The majority of patients with Hodgkin Lymphoma (HL)are cured with radiation therapy and/or combination chemotherapy. However, patients who relapse after attaining a complete remission with chemotherapy and those with primary refractory disease have a poor outcome with conventional chemotherapy regimens. Treatment results with standard−dose second−line regimens produce low complete remission rates and minimal survival benefit. Single institution studies have shown better outcome after autologous stem cell transplant in this group of patients when compared to historical controls receiving conventional treatment. In this retrospective review, we aim to analyze outcome and determine independent prognostic factors which would correlate with the long−term outcome of patients with HL who received an autologous stem cell transplant in the past at the Royal Marsden Hospital Eligible patients (those on current−follow−up) identified from the transplant database will be eligible for the study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a) Age over 18 b) Patients with Hodgkin Lymphoma who have received an autologous stem cell transplant 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

• Hodgkin Disease
• Hodgkin 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,