Enrichment & Purging of Stem Cells in Non-Hodgkin's Lymphoma | NCT00186355

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

NCT00186355

Sponsor

Stanford University

Status

Completed

Last Update Posted

May 14, 2012Estimated

Enrollment

97Actual

Phase

Not Applicable

Conditions

Lymphoma, Non-Hodgkin

Interventions

high dose chemo then auto hematopoietic cell transplant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
77063	Other Identifier	Stanford University Alternate IRB Approval Number
NCT00186355
12170	Other Identifier	Stanford IRB

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Mar 2007Actual

Completion Date

Feb 2010Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2012

Last Update Posted Date

May 14, 2012Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Name	Type	Description	Arm Group Labels	Other Names
high dose chemo then auto hematopoietic cell transplant	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PCR positivity in peripheral blood cell collections after cyclophosphamide

Secondary Outcomes

Measure	Description	Time Frame
Enrichment of hematopoietic stem cells

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Weeks

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert S Negrin	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided