HD18 for Advanced Stages in Hodgkins Lymphoma

University of Cologne1,500 enrolled

Overview

This study is designed to test: 1. in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles) 2. for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,500

Conditions

Hodgkins Lymphoma

Interventions

RituximabDRUG

addition of Rituximab to BEACOPP escalated

BEACOPP escalatedDRUG

chemotherapy with BEACOPP escalated

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hodgkin Lymphoma (histologically proven) * CS (PS) IIB with one or both of the risk factors: * bulky mediastinal mass (\> 1/3 of maximum transverse thorax diameter) * extranodal involvement * CS (PS) III, IV * Written informed consent Exclusion Criteria: * Leucocytes \< 3000/µl * Platelets \< 100000/µl * Hodgkin´s lymphoma as "composite lymphoma" * Activity index (WHO) \< grade 2

Locations (1)

1st Dept. of Medicine, Cologne University Hospital

Cologne, Germany

Outcomes

Primary Outcomes

Progression Free Survival

Time frame: 5 years

Secondary Outcomes

Overall Survival

Time frame: 5 years

acute toxicity

Time frame: 5 years

late toxicity

Time frame: 5 years

CR-rate

Time frame: 5 years

Data from ClinicalTrials.gov

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