Overview

This trial is active, not recruiting.

Condition hodgkins lymphoma
Treatments rituximab, beacopp escalated
Phase phase 3
Target CD20
Sponsor University of Cologne
Start date May 2008
End date June 2020
Trial size 1500 participants
Trial identifier NCT00515554, HD18

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
8 cycles BEACOPPesc
beacopp escalated
chemotherapy with BEACOPP escalated
(Experimental)
8 cycles BEACOPPesc plus rituximab
rituximab
addition of Rituximab to BEACOPP escalated
beacopp escalated
chemotherapy with BEACOPP escalated
(Active Comparator)
8 cycles BEACOPPesc
beacopp escalated
chemotherapy with BEACOPP escalated
(Experimental)
4 cycles BEACOPPesc
beacopp escalated
chemotherapy with BEACOPP escalated

Primary Outcomes

Measure
Progression Free Survival
time frame: 5 years

Secondary Outcomes

Measure
Overall Survival
time frame: 5 years
acute toxicity
time frame: 5 years
late toxicity
time frame: 5 years
CR-rate
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Principal investigator Andreas Engert, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Cologne.