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| Name | Class |
|---|---|
| Hadassah Medical Organization | OTHER |
| Rabin Medical Center | OTHER |
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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. These findings strongly support the integration of interim PET as a decision point for adjustment of chemotherapy.This study use the minimal therapy considered safe according to the predefined risk factors for patients with interim negative PET. Those with pathologic interim study considered as higher risk patients will have dose escalation of therapy.remission rate ,event free survival and overall survival will be evaluated.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early favorable | Experimental | patients with early favorable disease Ia IIA will have a PET/CT following 2 cycles of ABVD |
|
| Early Unfavorable | Experimental | 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 |
|
| advanced disease | Experimental | 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 |
|
| advanced disease IPS 3-7 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT post 2 cycles of chemotherapy | Other | sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event Free survival in various risk groups of patients | five years | |
| Event Free Survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival5 years | 5 years | |
| event free survival 5 years | five years | |
| Disease free survival 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eldad J Dann, MD | RABMAM medical center ,Haifa Israel , Rappapport school of medicine Technion Israel technical Institute Haifa Israel | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RAMBAM health care campus | Haifa | 30063 | Israel |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| five years |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |