HD12 for Advanced Stages

NCT00265031 | Completed Phase 3

• 1 other identifier: HD12
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.

Conditions

Hodgkin´s Lymphoma

Keywords

Hodgkin´s Lymphoma; advanced stages

Interventions

Cyclophosphamide DRUG

Adriamycin DRUG

Etoposide DRUG

Procarbazine DRUG

Prednisone DRUG

Vincristine DRUG

Bleomycin DRUG

radiation therapy PROCEDURE

Eligibility Criteria

• Age: 16 Years - 65 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) IIB with one or both of the risk factors:
• bulky mediastinal mass (\> 1/3 of maximum transverse thorax diameter)
• extranodal involvement
• CS(PS) III, IV
• 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 (2)

• Borchmann P, Haverkamp H, Diehl V, Cerny T, Markova J, Ho AD, Eich HT, Mueller-Hermelink HK, Kanz L, Greil R, Rank A, Paulus U, Smardova L, Huber C, Dorken B, Nerl C, Krause SW, Mueller RP, Fuchs M, Engert A. Eight cycles of escalated-dose BEACOPP compared with four cycles of escalated-dose BEACOPP followed by four cycles of baseline-dose BEACOPP with or without radiotherapy in patients with advanced-stage hodgkin's lymphoma: final analysis of the HD12 trial of the German Hodgkin Study Group. J Clin Oncol. 2011 Nov 10;29(32):4234-42. doi: 10.1200/JCO.2010.33.9549. Epub 2011 Oct 11.

  PMID: 21990399 RESULT

• von Tresckow B, Kreissl S, Goergen H, Brockelmann PJ, Pabst T, Fridrik M, Rummel M, Jung W, Thiemer J, Sasse S, Burkle C, Baues C, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. Intensive treatment strategies in advanced-stage Hodgkin's lymphoma (HD9 and HD12): analysis of long-term survival in two randomised trials. Lancet Haematol. 2018 Oct;5(10):e462-e473. doi: 10.1016/S2352-3026(18)30140-6.

  PMID: 30290903 DERIVED

Related Links

• Description of study i German (Website of the Competence Network Malignant Lymphoma)

MeSH Terms

Interventions

Cyclophosphamide; Doxorubicin; Etoposide; Procarbazine; Prednisone; Vincristine; Bleomycin; Radiotherapy

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Therapeutics

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: January 1, 1999
• Last Updated: June 25, 2012

Record last verified: 2007-08