Condition category
Cancer
Date applied
11/09/2003
Date assigned
29/10/2003
Last edited
07/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Volker Diehl

ORCID ID

Contact details

German Hodgkin's Lymphoma Study Group
Herderstr. 52-54
Cologne
50924
Germany
+49/221/478-3557 (-3558)
dhsg@biometrie.uni-koeln.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HD15

Study hypothesis

Primary aim:
Reduction of toxicity, de-escalation of chemotherapy while maintaining high freedom from treatment failure (FFTF) and overall survival (OS) rates.

Secondary aims:
Assess the influence of erythropoietin on the quality of life and the effect of FDG-PET on prognosis.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information sheet can be found at http://www.lymphome.de/en/Groups/GHSG/Protocols/HD15/Patient-Information.pdf

Condition

Hodgkin's disease

Intervention

In this trial three combinations of chemotherapy are compared in a randomised, controlled trial (open-label). In addition patients in every arm are randomly assigned to receive erythropoetin or placebo (double-blind). Restaging with PET is not allocated in a randomised fashion:

Arm A:
1. 8 x erythropoietin, cyclophosphamide, adriamycin, etoposide, vincristine, bleomycin, procarbazine (BEACOPP) (escalated)
2. Erythropoetin/placebo
3. 30 Gy involved field radiotherapy if partial remission after chemotherapy and PET is positive

Arm B:
1. 6 x BEACOPP (escalated)
2. Erythropoetin/placebo
3. 30 Gy involved field radiotherapy if partial remission after chemotherapy and PET is positive

Arm C:
1. 8 x BEACOPP-14
2. Erythropoetin/placebo
3. 30 Gy involved field radiotherapy if partial remission after chemotherapy and PET is positive

Intervention type

Drug

Phase

Not Specified

Drug names

Erythropoietin, cyclophosphamide, adriamycin, etoposide, vincristine, bleomycin, procarbazine (BEACOPP)

Primary outcome measures

Freedom from treatment failure (FFTF).

Secondary outcome measures

Impact of erythropoetin on quality of life and prognostic significance of FDG-PET.

Overall trial start date

01/01/2003

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Chemotherapy:
1. Histologically confirmed Hodgkin's disease
2. Stage IIB and massive mediastinal involvement (tumour one third or more of the maximum intrathoracic diameter) and/or extranodal involvement, stage III, and stage IV
3. No prior therapy for Hodgkin's disease
4. Age: 18 - 60 years
5. No major organ dysfunction
6. Life expectancy greater than 3 months
7. Written informed consent

PET:
1. Chemotherapy according to the HD15-protocol
2. Response to chemotherapy
3. Partial response with residual disease of at least 2.5 cm maximum diameter

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Chemotherapy:
1. Incomplete staging
2. Major organ dysfunction:
2.1. Chronic obstructive pulmonary disease (COPD) with respiratory insufficiency
2.2. Symptomatic coronary heart disease (CHD)
2.3. Cardiomyopathy or heart failure (ejection fraction less than 50%)
2.4. Severe hypertension
2.5. Non-treatable infections
2.6. White blood count less than 3000/mm^3 or platelets less than 100,000/mm^3 if not related to bone marrow involvement
2.7. Creatinine clearance less than 60 ml/min
2.8. Bilirubin greater than 2 mg/dl if not related to Hodgkin's disease
2.9. Glutamic oxaloacetic transaminase (GOT)/aspartate aminotransferase (AST) greater than 100 U/l if not related to Hodgkin's disease
2.10. Glutamic pyruvic transaminase (GPT)/alanine aminotransferase (ALT) greater than 100 U/l if not related to Hodgkin's disease
2.11. Human immunodeficiency virus (HIV)-infection
3. Composite lymphoma
4. Prior chemotherapy or radiotherapy
5. Any history of another malignancy in the last 5 years (except for cervical carcinoma in situ and fully resected melanoma TNMpT1)
6. Pregnancy or breastfeeding
7. World Health Organisation (WHO) performance status greater than 2
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

PET:
1. Diabetes mellitus
2. Elevated blood glucose (greater than 130 mg/dl)
3. Massive bone involvement (endangering stability)

Recruitment start date

01/01/2003

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Germany

Trial participating centre

German Hodgkin's Lymphoma Study Group,
Cologne
50924
Germany

Sponsor information

Organisation

German Hodgkin's Lymphoma Study Group (Germany)

Sponsor details

Herderstr. 52-54
Cologne
50924
Germany
+49 (0)221 478-3557 (-3558)
dhsg@biometrie.uni-koeln.de

Sponsor type

Research organisation

Website

Funders

Funder type

Charity

Funder name

Deutsche Krebshilfe (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18757777
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22480758
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24799482

Publication citations

  1. Results

    Kobe C, Dietlein M, Franklin J, Markova J, Lohri A, Amthauer H, Klutmann S, Knapp WH, Zijlstra JM, Bockisch A, Weckesser M, Lorenz R, Schreckenberger M, Bares R, Eich HT, Mueller RP, Fuchs M, Borchmann P, Schicha H, Diehl V, Engert A, Positron emission tomography has a high negative predictive value for progression or early relapse for patients with residual disease after first-line chemotherapy in advanced-stage Hodgkin lymphoma., Blood, 2008, 112, 10, 3989-3994, doi: 10.1182/blood-2008-06-155820.

  2. Results

    Engert A, Haverkamp H, Kobe C, Markova J, Renner C, Ho A, Zijlstra J, Král Z, Fuchs M, Hallek M, Kanz L, Döhner H, Dörken B, Engel N, Topp M, Klutmann S, Amthauer H, Bockisch A, Kluge R, Kratochwil C, Schober O, Greil R, Andreesen R, Kneba M, Pfreundschuh M, Stein H, Eich HT, Müller RP, Dietlein M, Borchmann P, Diehl V, , , , Reduced-intensity chemotherapy and PET-guided radiotherapy in patients with advanced stage Hodgkin's lymphoma (HD15 trial): a randomised, open-label, phase 3 non-inferiority trial., Lancet, 2012, 379, 9828, 1791-1799, doi: 10.1016/S0140-6736(11)61940-5.

  3. Results

    Kobe C, Kuhnert G, Kahraman D, Haverkamp H, Eich HT, Franke M, Persigehl T, Klutmann S, Amthauer H, Bockisch A, Kluge R, Wolf HH, Maintz D, Fuchs M, Borchmann P, Diehl V, Drzezga A, Engert A, Dietlein M, Assessment of tumor size reduction improves outcome prediction of positron emission tomography/computed tomography after chemotherapy in advanced-stage Hodgkin lymphoma., J. Clin. Oncol., 2014, 32, 17, 1776-1781, doi: 10.1200/JCO.2013.53.2507.

Additional files

Editorial Notes