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

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: 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)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma
• Actual Study Start Date: January 13, 2012
• Actual Primary Completion Date: March 21, 2020
• Actual Study Completion Date: March 23, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arm A; 2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy	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	Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone); Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine); Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival [ Time Frame: 3 years ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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, German Hodgkin Study Group

More Information

Additional Information:

Homepage GHSG 

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

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.

• Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
• ClinicalTrials.gov Identifier: NCT01356680
• Other Study ID Numbers: HD17
• First Posted: May 19, 2011
• Last Update Posted: April 6, 2020
• Last Verified: April 2020

Keywords provided by Prof. Dr. Andreas Engert, University of Cologne:

Hodgkin Lymphoma; intermediate stage; PET

Additional relevant MeSH terms:

Lymphoma; Hodgkin Disease; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Prednisone; Cyclophosphamide; Dacarbazine; Etoposide; Vincristine; Doxorubicin; Liposomal doxorubicin; Bleomycin; Vinblastine; Procarbazine; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Anti-Inflammatory Agents; Glucocorticoids; Hormones