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HD16 for Early Stage Hodgkin Lymphoma

This study is currently recruiting participants.
Verified January 2013 by University of Cologne
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00736320
First received: August 8, 2008
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS).


Condition Intervention Phase
Hodgkin Lymphoma
 Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
Radiation: 20 Gy IFRT (Involved Field Radiotherapy)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET

Resource links provided by NLM:

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: 1100
Study Start Date: November 2009
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy
 Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
chemotherapy with 2 cycles of ABVD (day 1 + 15)
Radiation: 20 Gy IFRT (Involved Field Radiotherapy)
20 Gy Involved Field Radiotherapy
Experimental: B
2 cycles ABVD followed by 20 Gy IF-RT if FDG-PET is positive after chemotherapy; 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
 Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
chemotherapy with 2 cycles of ABVD (day 1 + 15)
Radiation: 20 Gy IFRT (Involved Field Radiotherapy)
20 Gy Involved Field Radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hodgkin Lymphoma

  • CS I, II without risk factors

    • large mediastinal mass (> 1/3 of maximum transverse thorax diameter)
    • extranodal involvement
    • elevated ESR
    • 3 or more involved nodal areas
  • Written informed consent

Exclusion Criteria:

  • Leucocytes < 3000/µl
  • Platelets < 100000/µl
  • Hodgkin Lymphoma as composite lymphoma
  • Activity index (WHO) > 2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736320

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

Locations
Germany
1st Dept. of Medicine, Cologne University Hospital Recruiting
Cologne, Germany
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

Additional Information:
Homepage GHSG  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00736320     History of Changes
Other Study ID Numbers: HD16
Study First Received: August 8, 2008
Last Updated: January 25, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
Hodgkin Lymphoma
early stage
PET

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Dacarbazine
Vincristine
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2013