HD16 for Early Stage Hodgkin Lymphoma (HD16)

• ClinicalTrials.gov Identifier: NCT00736320
• Recruitment Status: Unknown
• First Posted: August 15, 2008
• Last Update Posted: November 4, 2020
• Sponsor: University of Cologne
• Information provided by (Responsible Party): Prof. Dr. Andreas Engert, University of Cologne

Tracking Information

• First Submitted Date: August 8, 2008
• First Posted Date: August 15, 2008
• Last Update Posted Date: November 4, 2020
• Study Start Date: November 2009
• Actual Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 14, 2008): Progression Free Survival [ Time Frame: 5 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 28, 2010)

• overall survival [ Time Frame: 5 years ]
• acute toxicity [ Time Frame: 5 years ]
• late toxicity [ Time Frame: 5 years ]
• CR rate [ Time Frame: 5 years ]

• Original Secondary Outcome Measures (submitted: August 14, 2008): Overall survival, acute and late toxicity, CR-rate [ Time Frame: 5 years ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HD16 for Early Stage Hodgkin Lymphoma
• 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
• 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: 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

Study Arms

• Active Comparator: A
  2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy
  Interventions:

  • Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
  • Radiation: 20 Gy IFRT (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
  Interventions:

  • Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
  • Radiation: 20 Gy IFRT (Involved Field Radiotherapy)

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: January 27, 2016): 1150
• Original Estimated Enrollment (submitted: August 14, 2008): 1100
• Estimated Study Completion Date: December 2021
• Actual Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older 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: NCT00736320
• Other Study ID Numbers: HD16
• 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: Not Provided
• Current Study Sponsor: University of Cologne
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Andreas Engert, Prof.; University of Cologne

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