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The Prognostic Value of Interim PET/CT After 2 Cycles of Chemotherapy in Predicting Progression of Non Hodgkins Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
e_dann, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00498667
First received: July 8, 2007
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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.


Condition
Lymphoma; Large Cell (Diffuse) With Small Cell, Diffuse

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

no biopsies are to be retained


Estimated Enrollment: 150
Study Start Date: December 2006
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
PET/CT
all patients with aggressive lymphoma who had a baseline and interim pet/ct study

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

all patients with agressive non hodgkin lymphoma who had interim pet/ct during therapy

Criteria

Inclusion Criteria:

  • aggressive non-Hodgkin lymphoma b cells
  • age 18-70
  • bilirubin less then 2
  • creatinine less then 2
  • Pet/CT performed post 2 cycles

Exclusion Criteria:

  • no PET/CT post 2 cycles performed
  • bilirubin >2
  • creatinine more then 2
  • HIV positivity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498667

Locations
Israel
RAMBAM health care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Eldad J Dann, MD RAMBAM health care campus,Rappaport faculty of medicine Technion Israel Technical institute
  More Information

No publications provided

Responsible Party: e_dann, Prof Eldad Dann, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00498667     History of Changes
Other Study ID Numbers: cc-NHL2615_CTIL
Study First Received: July 8, 2007
Last Updated: November 4, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
PET/CT
Aggressive non-Hodgkin Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 20, 2014