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Enrichment & Purging of Stem Cells in Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high dose chemo then auto hematopoietic cell transplant
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin

Eligibility Criteria

4 Weeks - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:- relapsed NHL Exclusion Criteria:- liver dysfunction

Sites / Locations

  • Stanford University School of Medicine

Outcomes

Primary Outcome Measures

PCR positivity in peripheral blood cell collections after cyclophosphamide

Secondary Outcome Measures

Enrichment of hematopoietic stem cells

Full Information

First Posted
September 13, 2005
Last Updated
May 10, 2012
Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00186355
Brief Title
Enrichment & Purging of Stem Cells in Non-Hodgkin's Lymphoma
Official Title
Enrichment and Purging of Stem Cells in the Treatment of Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)

4. Oversight

5. Study Description

Brief Summary
To evaluate the role of purging the hematopoietic cell graft on outcomes for non-Hodgkin's Lymphoma.
Detailed Description
To study the use of peripheral blood stem cells which have been treated in an effort to remove tumor cells. The researchers hope to learn whether or not this will be more effective in removing the tumor cells as compared to other methods of purging (the removal of cancer cells).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
high dose chemo then auto hematopoietic cell transplant
Primary Outcome Measure Information:
Title
PCR positivity in peripheral blood cell collections after cyclophosphamide
Secondary Outcome Measure Information:
Title
Enrichment of hematopoietic stem cells

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- relapsed NHL Exclusion Criteria:- liver dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Negrin
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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Enrichment & Purging of Stem Cells in Non-Hodgkin's Lymphoma

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