HD17 for Intermediate Stage Hodgkin Lymphoma

University of Cologne1,100 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,100

Conditions

Hodgkin Lymphoma

Interventions

BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)DRUG

ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)DRUG

30Gy IF-RT (Involved-Field Radiotherapy)RADIATION

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

1st Dept. of Medicine, Cologne University Hospital

Cologne, Germany

Outcomes

Primary Outcomes

Progression Free Survival

Time frame: 3 years

Secondary Outcomes

Overall Survival

Time frame: 3 years

CR rate

Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment

Time frame: 6 months

Data from ClinicalTrials.gov

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