Tailored Therapy for Hodgkin Lymphoma Using Early Interim Therapy PET for Therapy Decision.
NCT ID: NCT00392314
Last Updated: 2014-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
365 participants
INTERVENTIONAL
2006-10-31
2014-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Early favorable
patients with early favorable disease Ia IIA will have a PET/CT following 2 cycles of ABVD
PET/CT post 2 cycles of chemotherapy
sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
Early Unfavorable
Patients with early favorable disease Ia or IIa with risk factors :large mediastinal mass extra nodal disease elevated esr, three or more involved areas, age equal or \>50 , lymphocytic depleted or mixed cellularity
PET/CT post 2 cycles of chemotherapy
sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
advanced disease
patients with advanced disease low IPS score 0-2 will start chemotherapy with ABVD for 2 cycles followed by PET/CT further therapy will be given according to PET/CT results
PET/CT post 2 cycles of chemotherapy
sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
advanced disease IPS 3-7
Patients with advanced disease IPS score 3-7 will start chemotherapy with escalated beacopp. following 2 cycles PET/CT will be carried out and according to results further chemotherapy will be given
PET/CT post 2 cycles of chemotherapy
sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
Interventions
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PET/CT post 2 cycles of chemotherapy
sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Rabin Medical Center
OTHER
Rambam Health Care Campus
OTHER
Responsible Party
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e_dann
Eldad J Dann assoc Prof of Hematology (Clinical), director of blood bank and aphaeresis unit RAMBAM health care campus Haifa Israel
Principal Investigators
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Eldad J Dann, MD
Role: STUDY_CHAIR
RABMAM medical center ,Haifa Israel , Rappapport school of medicine Technion Israel technical Institute Haifa Israel
Locations
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RAMBAM health care campus
Haifa, , Israel
Countries
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Other Identifiers
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ISRA2432_CTIL
Identifier Type: -
Identifier Source: org_study_id
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