Phase 2 Study.Tailored Therapy for Hodgkin Lymphoma Based on Predefined Risk Factors and Early Interim PET/CT for Response Assessment and Further Therapy Decisions.
18 Years
60 Years
Both
Hodgkin Lymphoma
Trial Information
Phase 2 Study.Tailored Therapy for Hodgkin Lymphoma Based on Predefined Risk Factors and Early Interim PET/CT for Response Assessment and Further Therapy Decisions.
study aim is to tailor the therapy in order to administer the lowest cumulative dose of
therapy yet considered safe in order to reduce both early and late therapy related
complications.
patients will be divided according to risk factors to sub groups of early favorable, early
unfavorable, advanced disease with score less then 3 points or higher then 3 points.
Early Interim PET will be carried out Further therapy will be based on the study results.
Inclusion Criteria:
- Hodgkin lymphoma patients
- age 18-60 for those with early disease and advanced disease with score less then 3
- age 18-60 years for patients with advanced disease score 3 or higher classical
Hodgkin lymphoma
- WBC more then 3500
- platelets more then 100000
- creatinin less then 2.0 mg
- bilirubin less then 2.0 mg
- absolute neutrophil count more then 1000 unless bone marrow involvement If marrow
involve, patient with lower count but ANC of 1000 may be included.
Exclusion Criteria:
- Positive serology for HIV
- bilirubin more then 2 mg/dl
- creatinin more then 2 mg/dl
- lactating woman or pregnant
- patient older then 60 years with high risk disease of score 3 or more
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event Free survival in various risk groups of patients
Outcome Time Frame:
five years
Safety Issue:
No
Principal Investigator
Eldad J Dann, MD
Investigator Role:
Study Chair
Investigator Affiliation:
RABMAM medical center ,Haifa Israel , Rappapport school of medicine Technion Israel technical Institute Haifa Israel
Authority:
Israel: Israeli Health Ministry Pharmaceutical Administration
Study ID:
ISRA2432_CTIL
NCT ID:
NCT00392314
Start Date:
October 2006
Completion Date:
October 2016
Related Keywords:
- Hodgkin Lymphoma
- hodgkin lymphoma
- PET/CT
- Therapy
- Hodgkin Disease
- Lymphoma
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