Tailored Therapy for Hodgkin Lymphoma Using Early Interim Therapy PET for Therapy Decision.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Hodgkin Lymphoma

Intervention / Treatment
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* Other: PET/CT post 2 cycles of chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early favorable<br>patients with early favorable disease Ia IIA will have a PET/CT following 2 cycles of ABVD | Other: PET/CT post 2 cycles of chemotherapy<br>* sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy<br>* Other names: F18 deoxyglucose scintigraphy;|
| Experimental: Early Unfavorable<br>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 | Other: PET/CT post 2 cycles of chemotherapy<br>* sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy<br>* Other names: F18 deoxyglucose scintigraphy;|
| Experimental: advanced disease<br>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 | Other: PET/CT post 2 cycles of chemotherapy<br>* sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy<br>* Other names: F18 deoxyglucose scintigraphy;|
| Experimental: advanced disease IPS 3-7<br>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 | Other: PET/CT post 2 cycles of chemotherapy<br>* sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy<br>* Other names: F18 deoxyglucose scintigraphy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free survival in various risk groups of patients |  | five years | 
| Event Free Survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival5 years |  | 5 years | 
| event free survival 5 years |  | five years | 
| Disease free survival 5 years |  | five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hodgkin lymphoma, PET/CT, Therapy