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HD18 for Advanced Stages in Hodgkins Lymphoma

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00515554
Enrollment
1500
Registered
2007-08-13
Start date
2008-05-31
Completion date
2020-07-31
Last updated
2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkins Lymphoma

Keywords

Hodgkin lymphoma, PET, advances stages, Rituximab

Brief summary

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.

Interventions

DRUGRituximab

addition of Rituximab to BEACOPP escalated

DRUGBEACOPP escalated

chemotherapy with BEACOPP escalated

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Progression Free Survival5 years

Secondary

MeasureTime frame
Overall Survival5 years
acute toxicity5 years
late toxicity5 years
CR-rate5 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026