HD17 for Intermediate Stage Hodgkin Lymphoma

• ClinicalTrials.gov Identifier: NCT01356680
• Recruitment Status: Completed
• First Posted: May 19, 2011
• Last Update Posted: April 6, 2020
• Sponsor: University of Cologne
• Information provided by (Responsible Party): Prof. Dr. Andreas Engert, University of Cologne

Tracking Information

• First Submitted Date: May 13, 2011
• First Posted Date: May 19, 2011
• Last Update Posted Date: April 6, 2020
• Actual Study Start Date: January 13, 2012
• Actual Primary Completion Date: March 21, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 17, 2011): Progression Free Survival [ Time Frame: 3 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 16, 2014)

• Overall Survival [ Time Frame: 3 years ]
• CR rate [ Time Frame: 6 months ]
  Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment

Original Secondary Outcome Measures (submitted: May 17, 2011)

• Overall Survival [ Time Frame: 3 years ]
• CR rate
  Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HD17 for Intermediate Stage Hodgkin Lymphoma
• Official Title: HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hodgkin Lymphoma

Intervention

• Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
• Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
• Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)
• Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)

Study Arms

• Active Comparator: Arm A
  2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy
  Interventions:

  • Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
  • Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
  • Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)
• Experimental: Arm B
  2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
  Interventions:

  • Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
  • Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
  • Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)

Publications *

• Borchmann P, Plutschow A, Kobe C, Greil R, Meissner J, Topp MS, Ostermann H, Dierlamm J, Mohm J, Thiemer J, Sokler M, Kerkhoff A, Ahlborn M, Halbsguth TV, Martin S, Keller U, Balabanov S, Pabst T, Vogelhuber M, Huttmann A, Wilhelm M, Zijlstra JM, Moccia A, Kuhnert G, Brockelmann PJ, von Tresckow B, Fuchs M, Klimm B, Rosenwald A, Eich H, Baues C, Marnitz S, Hallek M, Diehl V, Dietlein M, Engert A. PET-guided omission of radiotherapy in early-stage unfavourable Hodgkin lymphoma (GHSG HD17): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):223-234. doi: 10.1016/S1470-2045(20)30601-X.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 17, 2011): 1100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 23, 2020
• Actual Primary Completion Date: March 21, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Hodgkin Lymphoma
• CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01356680
• Other Study ID Numbers: HD17
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Prof. Dr. Andreas Engert, University of Cologne
• Original Responsible Party: Prof. Dr. Andreas Engert, German Hodgkin Study Group
• Current Study Sponsor: University of Cologne
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Andreas Engert, Prof.; University of Cologne, German Hodgkin Study Group

• PRS Account: University of Cologne
• Verification Date: April 2020