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HD18 for Advanced Stages in Hodgkins Lymphoma

This study is currently recruiting participants.
Verified March 2012 by University of Cologne
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00515554
First received: August 10, 2007
Last updated: April 2, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Hodgkins Lymphoma
 Drug: Rituximab
Drug: BEACOPP escalated
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • acute toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • late toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • CR-rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: May 2008
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515554

Contacts
Contact: Michael Fuchs GHSG@uk-koeln.de

Locations
Germany
1st Dept. of Medicine, Cologne University Hospital Recruiting
Cologne, Germany, 50924
Contact: Andreas Engert, Prof.         a.engert@uni-koeln.de    
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Andreas Engert, Prof. University of Cologne
  More Information

No publications provided by University of Cologne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00515554     History of Changes
Other Study ID Numbers: HD18
Study First Received: August 10, 2007
Last Updated: April 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
Hodgkin lymphoma
PET
advances stages
Rituximab

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013