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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00301314
First Posted: March 10, 2006
Last Update Posted: January 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royal Marsden NHS Foundation Trust
  Purpose

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.


Condition Intervention
Hodgkin Lymphoma Procedure: Autologous stem cell transplant

Study Type: Observational
Study Design: Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
219 participants aged over 18 with Hodgkin Lymphina who have received an autologous stem cell transplant and written informed consent.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301314


Locations
United Kingdom
Royal Marsden NHS trust
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: David Cunningham, FRCP Royal Marsden NHS Foundation Trust
  More Information

ClinicalTrials.gov Identifier: NCT00301314     History of Changes
Other Study ID Numbers: 2655
First Submitted: March 9, 2006
First Posted: March 10, 2006
Last Update Posted: January 12, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases