High Dose Chemotherapy Followed By PBSC Rescue for HD
Primary Purpose
Hodgkin Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high dose chemo then auto hematopoietic cell transplant
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Disease
Eligibility Criteria
Inclusion Criteria:- adequate organ function recurrent HD Exclusion Criteria:- CNS disease no prior malignancy
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
Overall survival
FFS
Response rates
Secondary Outcome Measures
Toxicity of high dose chemotherapy
Full Information
NCT ID
NCT00186251
First Posted
September 13, 2005
Last Updated
November 9, 2012
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT00186251
Brief Title
High Dose Chemotherapy Followed By PBSC Rescue for HD
Official Title
Use of High Dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
To evaluate the role of high dose chemotherapy with autologous hematopoietic cell transplantation in the treatment of Hodgkin's Disease.
Detailed Description
Use of High Dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
high dose chemo then auto hematopoietic cell transplant
Primary Outcome Measure Information:
Title
Overall survival
Title
FFS
Title
Response rates
Secondary Outcome Measure Information:
Title
Toxicity of high dose chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- adequate organ function
recurrent HD Exclusion Criteria:- CNS disease
no prior malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sally Arai
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
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High Dose Chemotherapy Followed By PBSC Rescue for HD
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