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HD16 for Early Stage Hodgkin Lymphoma (HD16)

Primary Purpose

Hodgkin Lymphoma

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
20 Gy IFRT (Involved Field Radiotherapy)
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Hodgkin Lymphoma, early stage, PET

Eligibility Criteria

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

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

Sites / Locations

  • 1st Dept. of Medicine, Cologne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy

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

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

overall survival
acute toxicity
late toxicity
CR rate

Full Information

First Posted
August 8, 2008
Last Updated
November 3, 2020
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT00736320
Brief Title
HD16 for Early Stage Hodgkin Lymphoma
Acronym
HD16
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 Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
Hodgkin Lymphoma, early stage, PET

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy
Arm Title
B
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
Intervention Description
chemotherapy with 2 cycles of ABVD (day 1 + 15)
Intervention Type
Radiation
Intervention Name(s)
20 Gy IFRT (Involved Field Radiotherapy)
Intervention Description
20 Gy Involved Field Radiotherapy
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
5 years
Title
acute toxicity
Time Frame
5 years
Title
late toxicity
Time Frame
5 years
Title
CR rate
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Engert, Prof.
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Dept. of Medicine, Cologne University Hospital
City
Cologne
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
35717166
Citation
van Heek L, Stuka C, Kaul H, Muller H, Mettler J, Hitz F, Baues C, Fuchs M, Borchmann P, Engert A, Dietlein M, Voltin CA, Kobe C. Predictive value of baseline metabolic tumor volume in early-stage favorable Hodgkin Lymphoma - Data from the prospective, multicenter phase III HD16 trial. BMC Cancer. 2022 Jun 18;22(1):672. doi: 10.1186/s12885-022-09758-z.
Results Reference
derived
PubMed Identifier
31498753
Citation
Fuchs M, Goergen H, Kobe C, Kuhnert G, Lohri A, Greil R, Sasse S, Topp MS, Schafer E, Hertenstein B, Soekler M, Vogelhuber M, Zijlstra JM, Keller UB, Krause SW, Wilhelm M, Maschmeyer G, Thiemer J, Duhrsen U, Meissner J, Viardot A, Eich H, Baues C, Diehl V, Rosenwald A, von Tresckow B, Dietlein M, Borchmann P, Engert A. Positron Emission Tomography-Guided Treatment in Early-Stage Favorable Hodgkin Lymphoma: Final Results of the International, Randomized Phase III HD16 Trial by the German Hodgkin Study Group. J Clin Oncol. 2019 Nov 1;37(31):2835-2845. doi: 10.1200/JCO.19.00964. Epub 2019 Sep 10.
Results Reference
derived
PubMed Identifier
30010775
Citation
Voltin CA, Goergen H, Baues C, Fuchs M, Mettler J, Kreissl S, Oertl J, Klaeser B, Moccia A, Drzezga A, Engert A, Borchmann P, Dietlein M, Kobe C. Value of bone marrow biopsy in Hodgkin lymphoma patients staged by FDG PET: results from the German Hodgkin Study Group trials HD16, HD17, and HD18. Ann Oncol. 2018 Sep 1;29(9):1926-1931. doi: 10.1093/annonc/mdy250.
Results Reference
derived
PubMed Identifier
25964643
Citation
Narang AK, Terezakis SA. Contemporary radiation therapy in combined modality therapy for Hodgkin lymphoma. J Natl Compr Canc Netw. 2015 May;13(5):597-605. doi: 10.6004/jnccn.2015.0077.
Results Reference
derived
Links:
URL
http://www.ghsg.org
Description
Homepage GHSG

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HD16 for Early Stage Hodgkin Lymphoma

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