HD18 for Advanced Stages in Hodgkins Lymphoma

• Sponsor: University of Cologne (Other)
• Overall Status: Completed
• CT.gov ID: NCT00515554
• Collaborator: (none)
• Enrollment: 1,500
• Location: 1
• Arms: 4
• Actual Duration (Months): 146
• Patients Per Site Per Month: 10.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkins Lymphoma	Drug: Rituximab; Drug: BEACOPP escalated	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: May 1, 2008
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A 8 cycles BEACOPPesc	Drug: BEACOPP escalated; chemotherapy with BEACOPP escalated
Experimental: B 8 cycles BEACOPPesc plus rituximab	Drug: Rituximab; addition of Rituximab to BEACOPP escalated; Drug: BEACOPP escalated; chemotherapy with BEACOPP escalated
Active Comparator: C 8 cycles BEACOPPesc	Drug: BEACOPP escalated; chemotherapy with BEACOPP escalated
Experimental: D 4 cycles BEACOPPesc	Drug: BEACOPP escalated; chemotherapy with BEACOPP escalated

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival [5 years]

Secondary Outcome Measures

1. Overall Survival [5 years]

2. acute toxicity [5 years]

3. late toxicity [5 years]

4. CR-rate [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1st Dept. of Medicine, Cologne University Hospital	Cologne		Germany	50924

Sponsors and Collaborators

• University of Cologne

Investigators

• Principal Investigator: Andreas Engert, Prof., University of Cologne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
• ClinicalTrials.gov Identifier: NCT00515554
• Other Study ID Numbers: HD18
• First Posted: Aug 13, 2007
• Last Update Posted: Nov 13, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Prof. Dr. Andreas Engert, Prof., University of Cologne: Hodgkin lymphoma; PET; advances stages; Rituximab
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease; Rituximab

Study Results

No Results Posted as of Nov 13, 2020