HD17 for Intermediate Stage Hodgkin Lymphoma

Study Overview
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Brief Summary
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This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS).

Official Title
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HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma

Conditions
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Hodgkin Lymphoma

Intervention / Treatment
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* Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
* Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
* Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)
* Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hodgkin Lymphoma CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included) large mediastinal mass (>1/3 of maximum transverse thorax diameter) extranodal involvement elevated ESR 3 or more involved nodal areas written informed consent Exclusion Criteria: Leucocytes <3000/µl Platelets < 100000/µl Hodgkin Lymphoma as composite lymphoma Activity Index (WHO) >2

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy | Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)<br> <br> Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)<br> <br> Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)<br> <br> |
| Experimental: Arm B<br>2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy | Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)<br> <br> Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)<br> <br> Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3 years | 
| CR rate | Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hodgkin Lymphoma, intermediate stage, PET