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HD16 for Early Stage Hodgkin Lymphoma (HD16)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00736320
Recruitment Status : Active, not recruiting
First Posted : August 15, 2008
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine) Radiation: 20 Gy IFRT (Involved Field Radiotherapy) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2009
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
  2. acute toxicity [ Time Frame: 5 years ]
  3. late toxicity [ Time Frame: 5 years ]
  4. CR rate [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Prof. Dr. Andreas Engert, 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