HD13 for early stage Hodgkin's disease: quality assurance protocol for reduction of toxicity in the first-line treatment of early stage Hodgkin's Disease (HD)

Conditions

Hodgkin's disease Cancer Hodgkin's disease

Stephanie Sasse, Helen Goergen, Annette Plütschow, Boris Böll, Dennis A. Eichenauer et al. (17 authors)

Journal of Clinical Oncology2018-07-107 citations

10.1200/jco.2018.78.7192

Risk factors and a prognostic score for survival after autologous stem-cell transplantation for relapsed or refractory Hodgkin lymphoma.

Bröckelmann PJ, Müller H, Casasnovas O, Hutchings M, von Tresckow B, Jürgens M, McCall SJ, Morschhauser F, Fuchs M, Borchmann P, Moskowitz CH, Engert A.

2017-06-0158 citations

10.1093/annonc/mdx072

Kreissl S, Mueller H, Goergen H, Mayer A, Brillant C, Behringer K, Halbsguth TV, Hitz F, Soekler M, Shonukan O, Rueffer JU, Flechtner HH, Fuchs M, Diehl V, Engert A, Borchmann P, German Hodgkin Study Group.

2016-09-0672 citations

10.1016/s1470-2045(16)30093-6

Bleomycin in older early-stage favorable Hodgkin lymphoma patients: analysis of the German Hodgkin Study Group (GHSG) HD10 and HD13 trials

Boris Böll, Helen Goergen, Karolin Behringer, Paul J. Bröckelmann, Felicitas Hitz et al. (15 authors)

Blood2016-02-02112 citations

10.1182/blood-2015-11-681064

Omission of dacarbazine or bleomycin, or both, from the ABVD regimen in treatment of early-stage favourable Hodgkin's lymphoma (GHSG HD13): an open-label, randomised, non-inferiority trial.

Behringer K, Goergen H, Hitz F, Zijlstra JM, Greil R, Markova J, Sasse S, Fuchs M, Topp MS, Soekler M, Mathas S, Meissner J, Wilhelm M, Koch P, Lindemann HW, Schalk E, Semrau R, Kriz J, Vieler T, Bentz M, Lange E, Mahlberg R, Hassler A, Vogelhuber M, Hahn D, Mezger J, Krause SW, Skoetz N, Böll B, von Tresckow B, Diehl V, Hallek M, Borchmann P, Stein H, Eich H, Engert A, German Hodgkin Study Group, Swiss Group for Clinical Cancer Research, Arbeitsgemeinschaft Medikamentöse Tumortherapie.

2014-12-22114 citations

10.1016/s0140-6736(14)61469-0

Interventions

Arm A: 2 x Doxorubicin, Bleomycin, Vinblastine, Dacarbazine (ABVD) and 30 Gy Involved Field Radiotherapy (IF-RT) Arm B: 2 x Doxorubicin, Bleomycin, Vinblastine (ABV) and 30 Gy IF-RT Arm C: 2 x Doxorub

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed Hodgkin's disease 2. Stages IA (not lympocyte predominant HD), IB, IIA, and IIB without the following risk factors: 2.1. Massive mediastinal involvement (tumour one third or more of the maximum intrathoracic diameter 2.2. Extranodal involvement 2.3. High Erythrocyte Sedimentation Rate (ESR) (greater than or equal to 50 mm; greater than or equal to 30 mm with B symptoms) 2.4. Three or more involved lymph node areas 3. No prior therapy for Hodgkin's disease 4. Aged 18 - 75 years 5. No major organ dysfunction 6. Life expectancy more than three months 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Incomplete staging 2. Major organ dysfunction (Chronic Obstructive Pulmonary Disease [COPD] with respiratory insufficiency, symptomatic Coronary Heart Disease [CHD], cardiomyopathy or heart failure [ejection fraction less than 50%], severe hypertension, non-treatable infections, white blood count less than 3000/mm^3 or platelets less than 100,000/mm^3, creatinine clearance less than 60 ml/min, bilirubin more than 2 mg/dl, Glutamic-Oxaloacetic Transaminase [GOT]/aspartate aminotransferase [AST] more than 100 U/l, Glutamic-Pyruvic Transaminase [GPT]/alanine aminotransferase [ALT] more than 100 U/l, Human Immunodeficiency Virus [HIV]-infection) 3. Composite lymphoma 4. Prior chemotherapy or radiotherapy 5. Any history of another malignancy in the last five years (except for cervical carcinoma in situ and fully resected melanoma TNMpT1) 6. Pregnancy or breastfeeding 7. World Health Organization (WHO) performance status more than two 8. Long term use of corticosteroids (e.g. for arthritis) or antineoplastic substances (e.g. methotrexate) 9. Expected non compliance 10. Current therapy for epilepsy 11. Intolerabilities against study drugs 12. Inability to give truly informed consent

Design outcomes

Primary

Measure	Time frame
Freedom From Treatment Failure (FFTF) .	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

Germany

Outcome results

None listed