HD17 for Intermediate Stage Hodgkin Lymphoma

University of Cologne

Status and phase: Completed; Phase 3

Conditions: Hodgkin Lymphoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01356680

HD17

Details and patient eligibility

About

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).

Enrollment: 1,100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 2 patient groups

Arm A

Active Comparator group

Description:

2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy

Treatment:

Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)

Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)

Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)

Arm B

Experimental group

Description:

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

Treatment:

Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)

Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)

Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)