Lymphoma, Non-HodgkinNCT00186355
Enrichment & Purging of Stem Cells in Non-Hodgkin's Lymphoma
A study testing high dose chemo then auto hematopoietic cell transplant in people with Lymphoma, Non-Hodgkin, run by Stanford University at 1 site in United States.
Trial summary
To evaluate the role of purging the hematopoietic cell graft on outcomes for non-Hodgkin's Lymphoma. Read more about this study
- Who is it for?
- Ages 4 weeks to 75 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- high dose chemo then auto hematopoietic cell transplant
- Type of treatment
- Surgery or procedure
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria:- relapsed NHL Exclusion Criteria:- liver dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Enrichment and Purging of Stem Cells in the Treatment of Non-Hodgkin's Lymphoma
To evaluate the role of purging the hematopoietic cell graft on outcomes for non-Hodgkin's Lymphoma.
Read the 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).
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- high dose chemo then auto hematopoietic cell transplant
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dose chemo then auto hematopoietic cell transplantProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR positivity in peripheral blood cell collections after cyclophosphamide
Secondary outcomes (1)
Enrichment of hematopoietic stem cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionMar 2007
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Robert S Negrin, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186355
- Sponsor's protocol ID
- BMT4IJ
- Other IDs
- 77063, NCT00186355, 12170
- Status last verified
- May 2012
- First submitted
- 13 Sep 2005
- Last updated
- 14 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enrichment and Purging of Stem Cells in the Treatment of Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00186355
- Acronym / sponsor ID
- BMT4IJ
- Conditions
- Lymphoma, Non-Hodgkin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 4 weeks to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high dose chemo then auto hematopoietic cell transplant | Procedure or surgery | – |
Primary outcome
PCR positivity in peripheral blood cell collections after cyclophosphamide
1 secondary outcome
Enrichment of hematopoietic stem cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Negrin principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high dose chemo then auto hematopoietic cell transplant in people with Lymphoma, Non-Hodgkin, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCR positivity in peripheral blood cell collections after cyclophosphamide. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2012.