Status:
COMPLETED
Tailored Therapy for Hodgkin Lymphoma Using Early Interim Therapy PET for Therapy Decision.
Lead Sponsor:
Rambam Health Care Campus
Collaborating Sponsors:
Hadassah Medical Organization
Rabin Medical Center
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Recently published studies demonstrated very high event free survival for patients with a normal interim PET/CT and a high hazard ratio for progression of an interim positive (pathological)study. Thes...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT00392314
Start Date
October 1 2006
End Date
May 1 2014
Last Update
May 9 2014
Active Locations (1)
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1
RAMBAM health care campus
Haifa, Israel, 30063