HD18 for Advanced Stages in Hodgkins Lymphoma

Hodgkins Lymphoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515554
• Other study ID #: HD18
• Status: Completed
• Phase: Phase 3
• Start date: May 2008
• Est. completion date: July 2020

Study information

• Verified date: November 2020
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: July 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkins Lymphoma
• Lymphoma

Intervention

Drug:
• Rituximab
addition of Rituximab to BEACOPP escalated
• BEACOPP escalated
chemotherapy with BEACOPP escalated

Locations

Country	Name	City	State
Germany	1st Dept. of Medicine, Cologne University Hospital	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		5 years
Secondary	Overall Survival		5 years
Secondary	acute toxicity		5 years
Secondary	late toxicity		5 years
Secondary	CR-rate		5 years