Lymphoma; Large Cell (Diffuse) With Small Cell, DiffuseNCT00498667
The Prognostic Value of Interim PET/CT After 2 Cycles of Chemotherapy in Predicting Progression of Non Hodgkins Lymphoma
An observational study of Lymphoma; Large Cell (Diffuse) With Small Cell, Diffuse, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
A retrospective analysis will be performed regarding the usefulness of PET/CT performed following 2 cycle of chemotherapy in evaluation of progression, free survival and overall survival of patients with aggressive non Hodgkin Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma; Large Cell (Diffuse) With Small Cell, Diffuse
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2006to Dec 2014
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients with agressive non hodgkin lymphoma who had interim pet/ct during therapy
Who may be able to join
- aggressive non-Hodgkin lymphoma b cells
- age 18-70
- bilirubin less then 2
- creatinine less then 2
- Pet/CT performed post 2 cycles
Who cannot join
- no PET/CT post 2 cycles performed
- bilirubin >2
- creatinine more then 2
- HIV positivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prognostic Value of Early Interim PET/CT for Prediction of Progression Free Survival of Patients With Aggressive B Cells Non Hodgkin Lymphoma
A retrospective analysis will be performed regarding the usefulness of PET/CT performed following 2 cycle of chemotherapy in evaluation of progression, free survival and overall survival of patients with aggressive non Hodgkin Lymphoma.
Read the detailed description
Patients who were treated for aggressive non-Hodgkin lymphoma with adriamycin containing regimen, CHOP and High dose CHOP with or without rituximab were evaluated post 2 cycles of chemotherapy to rule out disease progression . Currently a retrospective evaluation of PET/CT as a predictive value for progression free survival and overall survival is evaluated
- Keywords
- PET/CT, Aggressive non-Hodgkin Lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PET/CT | all patients with aggressive lymphoma who had a baseline and interim pet/ct study |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startDec 2006
- Primary completionDec 2009
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma; Large Cell (Diffuse) With Small Cell, DiffuseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, e_dann, Rambam Health Care Campus
- Investigators
- Eldad J Dann, MD, Principal investigator, RAMBAM health care campus,Rappaport faculty of medicine Technion Israel Technical institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498667
- Sponsor's protocol ID
- cc-NHL2615_CTIL
- Status last verified
- May 2015
- First submitted
- 8 Jul 2007
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prognostic Value of Early Interim PET/CT for Prediction of Progression Free Survival of Patients With Aggressive B Cells Non Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT00498667
- Acronym / sponsor ID
- cc-NHL2615_CTIL
- Keywords
- PET/CT, Aggressive non-Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Jul 2007 (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.
A retrospective analysis will be performed regarding the usefulness of PET/CT performed following 2 cycle of chemotherapy in evaluation of progression, free survival and overall survival of patients with aggressive non Hodgkin Lymphoma.
Detailed description
Patients who were treated for aggressive non-Hodgkin lymphoma with adriamycin containing regimen, CHOP and High dose CHOP with or without rituximab were evaluated post 2 cycles of chemotherapy to rule out disease progression . Currently a retrospective evaluation of PET/CT as a predictive value for progression free survival and overall survival is evaluated
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT | – | –all patients with aggressive lymphoma who had a baseline and interim pet/ct study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with agressive non hodgkin lymphoma who had interim pet/ct during therapy
Key inclusion criteria (5 listed)
- aggressive non-Hodgkin lymphoma b cells
- age 18-70
- bilirubin less then 2
- creatinine less then 2
- Pet/CT performed post 2 cycles
Key exclusion criteria (4 listed)
- no PET/CT post 2 cycles performed
- bilirubin >2
- creatinine more then 2
- HIV positivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
progression free survival
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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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.
Eldad J Dann, MD principal investigator
RAMBAM health care campus,Rappaport faculty of medicine Technion Israel Technical institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma; Large Cell (Diffuse) With Small Cell, Diffuse, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 6 May 2015. 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
progression free survival (time frame: 5 years). 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 6 May 2015.