HD16 for Early Stage Hodgkin Lymphoma

University of Cologne

Status and phase: Unknown; Phase 3

Conditions: Hodgkin Lymphoma

Treatments: Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine); Radiation: 20 Gy IFRT (Involved Field Radiotherapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT00736320

HD16

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: 1,150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hodgkin Lymphoma

• CS I, II without risk factors

  • 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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1,150 participants in 2 patient groups

A

Active Comparator group

Description:

2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy

Treatment:

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

Radiation: 20 Gy IFRT (Involved Field Radiotherapy)

B

Experimental group

Description:

2 cycles ABVD followed by 20 Gy IF-RT if FDG-PET is positive after chemotherapy; 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy

Treatment:

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

Radiation: 20 Gy IFRT (Involved Field Radiotherapy)