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HD16 for Early Stage Hodgkin Lymphoma (HD16)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne
ClinicalTrials.gov Identifier:
NCT00736320
First received: August 8, 2008
Last updated: January 27, 2016
Last verified: January 2016
  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:


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 ]

Enrollment: 1150
Study Start Date: November 2009
Estimated Primary Completion Date: May 2020 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736320

Locations
Germany
1st Dept. of Medicine, Cologne University Hospital
Cologne, Germany
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Andreas Engert, Prof. University of Cologne
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT00736320     History of Changes
Other Study ID Numbers: HD16 
Study First Received: August 8, 2008
Last Updated: January 27, 2016
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:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vincristine
Doxorubicin
Bleomycin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016