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HD10 for Early Stages

Primary Purpose

Hodgkin´s Lymphoma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Adriamycin
Bleomycin
Vinblastine
DTIC
30 Gy IF-RT
20 Gy IF-RT
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin´s Lymphoma focused on measuring Hodgkin´s lymphoma, early stages

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hodgkin´s lymphoma (histologically proven) CS (PS) IA, IB, IIA,IIB without any of the following risk factors: bulky mediastinal mass (> 1/3 maximum transverse thorax diameter) extranodal involvement ESR > 50 (A), > 30 (B-symptoms) 3 or more lymph node areas involved written informaed consent Exclusion Criteria: Leukocytes <3000/microl Platelets <100000/microl Hodgkin´s Disease as "composite lymphoma" Activity index (WHO) < grade 2

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Arm A

    Arm B

    Arm C

    Arm D

    Arm Description

    Outcomes

    Primary Outcome Measures

    Progression free survival (PFS)

    Secondary Outcome Measures

    Full Information

    First Posted
    December 12, 2005
    Last Updated
    July 28, 2011
    Sponsor
    University of Cologne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00265018
    Brief Title
    HD10 for Early Stages
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1998 (undefined)
    Primary Completion Date
    January 2003 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Cologne

    4. Oversight

    5. Study Description

    Brief Summary
    This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hodgkin´s Lymphoma
    Keywords
    Hodgkin´s lymphoma, early stages

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1370 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A
    Arm Type
    Active Comparator
    Arm Title
    Arm B
    Arm Type
    Experimental
    Arm Title
    Arm C
    Arm Type
    Experimental
    Arm Title
    Arm D
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Adriamycin
    Intervention Type
    Drug
    Intervention Name(s)
    Bleomycin
    Intervention Type
    Drug
    Intervention Name(s)
    Vinblastine
    Intervention Type
    Drug
    Intervention Name(s)
    DTIC
    Intervention Type
    Radiation
    Intervention Name(s)
    30 Gy IF-RT
    Intervention Type
    Radiation
    Intervention Name(s)
    20 Gy IF-RT
    Primary Outcome Measure Information:
    Title
    Progression free survival (PFS)
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hodgkin´s lymphoma (histologically proven) CS (PS) IA, IB, IIA,IIB without any of the following risk factors: bulky mediastinal mass (> 1/3 maximum transverse thorax diameter) extranodal involvement ESR > 50 (A), > 30 (B-symptoms) 3 or more lymph node areas involved written informaed consent Exclusion Criteria: Leukocytes <3000/microl Platelets <100000/microl Hodgkin´s Disease as "composite lymphoma" Activity index (WHO) < grade 2
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Volker Diehl, Prof.
    Organizational Affiliation
    University of Cologne
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20818855
    Citation
    Engert A, Plutschow A, Eich HT, Lohri A, Dorken B, Borchmann P, Berger B, Greil R, Willborn KC, Wilhelm M, Debus J, Eble MJ, Sokler M, Ho A, Rank A, Ganser A, Trumper L, Bokemeyer C, Kirchner H, Schubert J, Kral Z, Fuchs M, Muller-Hermelink HK, Muller RP, Diehl V. Reduced treatment intensity in patients with early-stage Hodgkin's lymphoma. N Engl J Med. 2010 Aug 12;363(7):640-52. doi: 10.1056/NEJMoa1000067.
    Results Reference
    result
    PubMed Identifier
    29989855
    Citation
    Sasse S, Goergen H, Plutschow A, Boll B, Eichenauer DA, Fuchs M, Behringer K, Zijlstra JM, Greil R, Markova J, Topp MS, Meissner J, Neubauer A, Baues C, Engert A, Borchmann P, von Tresckow B. Outcome of Patients With Early-Stage Infradiaphragmatic Hodgkin Lymphoma: A Comprehensive Analysis From the German Hodgkin Study Group. J Clin Oncol. 2018 Sep 1;36(25):2603-2611. doi: 10.1200/JCO.2018.78.7192. Epub 2018 Jul 10.
    Results Reference
    derived
    PubMed Identifier
    26834240
    Citation
    Boll B, Goergen H, Behringer K, Brockelmann PJ, Hitz F, Kerkhoff A, Greil R, von Tresckow B, Eichenauer DA, Burkle C, Borchmann S, Fuchs M, Diehl V, Engert A, Borchmann P. Bleomycin in older early-stage favorable Hodgkin lymphoma patients: analysis of the German Hodgkin Study Group (GHSG) HD10 and HD13 trials. Blood. 2016 May 5;127(18):2189-92. doi: 10.1182/blood-2015-11-681064. Epub 2016 Feb 1.
    Results Reference
    derived
    PubMed Identifier
    24121121
    Citation
    Hay AE, Klimm B, Chen BE, Goergen H, Shepherd LE, Fuchs M, Gospodarowicz MK, Borchmann P, Connors JM, Markova J, Crump M, Lohri A, Winter JN, Dorken B, Pearcey RG, Diehl V, Horning SJ, Eich HT, Engert A, Meyer RM; Conducted by the NCIC Clinical Trials Group (Canada) and German Hodgkin Study Group (GHSG). An individual patient-data comparison of combined modality therapy and ABVD alone for patients with limited-stage Hodgkin lymphoma. Ann Oncol. 2013 Dec;24(12):3065-9. doi: 10.1093/annonc/mdt389. Epub 2013 Oct 11.
    Results Reference
    derived
    PubMed Identifier
    23509310
    Citation
    Boll B, Gorgen H, Fuchs M, Pluetschow A, Eich HT, Bargetzi MJ, Weidmann E, Junghanss C, Greil R, Scherpe A, Schmalz O, Eichenauer DA, von Tresckow B, Rothe A, Diehl V, Engert A, Borchmann P. ABVD in older patients with early-stage Hodgkin lymphoma treated within the German Hodgkin Study Group HD10 and HD11 trials. J Clin Oncol. 2013 Apr 20;31(12):1522-9. doi: 10.1200/JCO.2012.45.4181. Epub 2013 Mar 18.
    Results Reference
    derived
    Links:
    URL
    http://www.lymphome.de/Gruppen/GHSG/
    Description
    Description of study in Gereman (Website of the Competence Network Malignant Lymphoma

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    HD10 for Early Stages

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