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

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
• Actual Primary Completion Date: September 2018
• Estimated Study Completion Date: December 2021

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

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• 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

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:

Homepage GHSG 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
• ClinicalTrials.gov Identifier: NCT00736320
• Other Study ID Numbers: HD16
• First Posted: August 15, 2008
• Last Update Posted: November 4, 2020
• Last Verified: November 2020

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; Liposomal doxorubicin; Dacarbazine; 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; Antineoplastic Agents, Alkylating; Alkylating Agents