HD10 for Early Stages

NCT00265018 | Completed Phase 3

• 1 other identifier: HD10
• Study Type: interventional
• Target: 1,370
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.

Conditions

Hodgkin´s Lymphoma

Keywords

Hodgkin´s lymphoma; early stages

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  5 years

Study Arms (4)

Arm A

ACTIVE COMPARATOR

Drug: Adriamycin; Drug: Bleomycin; Drug: Vinblastine; Drug: DTIC; Radiation: 30 Gy IF-RT

Arm B

EXPERIMENTAL

Drug: Adriamycin; Drug: Bleomycin; Drug: Vinblastine; Drug: DTIC; Radiation: 20 Gy IF-RT

Arm C

EXPERIMENTAL

Drug: Adriamycin; Drug: Bleomycin; Drug: Vinblastine; Drug: DTIC; Radiation: 30 Gy IF-RT

Arm D

EXPERIMENTAL

Drug: Adriamycin; Drug: Bleomycin; Drug: Vinblastine; Drug: DTIC; Radiation: 20 Gy IF-RT

Interventions

Adriamycin DRUG

Arm A; Arm B; Arm C; Arm D

Bleomycin DRUG

Arm A; Arm B; Arm C; Arm D

Vinblastine DRUG

Arm A; Arm B; Arm C; Arm D

DTIC DRUG

Arm A; Arm B; Arm C; Arm D

30 Gy IF-RT RADIATION

Arm A; Arm C

20 Gy IF-RT RADIATION

Arm B; Arm D

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hodgkin´s lymphoma (histologically proven)
• CS (PS) IA, IB, IIA,IIB without any of the following risk factors:
• bulky mediastinal mass (\> 1/3 maximum transverse thorax diameter)
• extranodal involvement
• ESR \> 50 (A), \> 30 (B-symptoms)
• or more lymph node areas involved
• written informaed consent

You may not qualify if:

• Leukocytes \<3000/microl
• Platelets \<100000/microl
• Hodgkin´s Disease as "composite lymphoma"
• Activity index (WHO) \< grade 2

Sponsors & Collaborators

• University of Cologne: lead

Related Publications (5)

• Engert A, Plutschow A, Eich HT, Lohri A, Dorken B, Borchmann P, Berger B, Greil R, Willborn KC, Wilhelm M, Debus J, Eble MJ, Sokler M, Ho A, Rank A, Ganser A, Trumper L, Bokemeyer C, Kirchner H, Schubert J, Kral Z, Fuchs M, Muller-Hermelink HK, Muller RP, Diehl V. Reduced treatment intensity in patients with early-stage Hodgkin's lymphoma. N Engl J Med. 2010 Aug 12;363(7):640-52. doi: 10.1056/NEJMoa1000067.

  PMID: 20818855 RESULT

• Sasse S, Goergen H, Plutschow A, Boll B, Eichenauer DA, Fuchs M, Behringer K, Zijlstra JM, Greil R, Markova J, Topp MS, Meissner J, Neubauer A, Baues C, Engert A, Borchmann P, von Tresckow B. Outcome of Patients With Early-Stage Infradiaphragmatic Hodgkin Lymphoma: A Comprehensive Analysis From the German Hodgkin Study Group. J Clin Oncol. 2018 Sep 1;36(25):2603-2611. doi: 10.1200/JCO.2018.78.7192. Epub 2018 Jul 10.

  PMID: 29989855 DERIVED

• Boll B, Goergen H, Behringer K, Brockelmann PJ, Hitz F, Kerkhoff A, Greil R, von Tresckow B, Eichenauer DA, Burkle C, Borchmann S, Fuchs M, Diehl V, Engert A, Borchmann P. Bleomycin in older early-stage favorable Hodgkin lymphoma patients: analysis of the German Hodgkin Study Group (GHSG) HD10 and HD13 trials. Blood. 2016 May 5;127(18):2189-92. doi: 10.1182/blood-2015-11-681064. Epub 2016 Feb 1.

  PMID: 26834240 DERIVED

• Hay AE, Klimm B, Chen BE, Goergen H, Shepherd LE, Fuchs M, Gospodarowicz MK, Borchmann P, Connors JM, Markova J, Crump M, Lohri A, Winter JN, Dorken B, Pearcey RG, Diehl V, Horning SJ, Eich HT, Engert A, Meyer RM; Conducted by the NCIC Clinical Trials Group (Canada) and German Hodgkin Study Group (GHSG). An individual patient-data comparison of combined modality therapy and ABVD alone for patients with limited-stage Hodgkin lymphoma. Ann Oncol. 2013 Dec;24(12):3065-9. doi: 10.1093/annonc/mdt389. Epub 2013 Oct 11.

  PMID: 24121121 DERIVED

• Boll B, Gorgen H, Fuchs M, Pluetschow A, Eich HT, Bargetzi MJ, Weidmann E, Junghanss C, Greil R, Scherpe A, Schmalz O, Eichenauer DA, von Tresckow B, Rothe A, Diehl V, Engert A, Borchmann P. ABVD in older patients with early-stage Hodgkin lymphoma treated within the German Hodgkin Study Group HD10 and HD11 trials. J Clin Oncol. 2013 Apr 20;31(12):1522-9. doi: 10.1200/JCO.2012.45.4181. Epub 2013 Mar 18.

  PMID: 23509310 DERIVED

Related Links

• Description of study in Gereman (Website of the Competence Network Malignant Lymphoma

MeSH Terms

Interventions

Doxorubicin; Bleomycin; Vinblastine; Dacarbazine

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Volker Diehl, Prof.

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 13, 2005
• Study Start: May 1, 1998
• Primary Completion: January 1, 2003
• Last Updated: July 29, 2011

Record last verified: 2011-07