Clinical Trial Results:
EuroNet-Paediatric Hodgkin’s Lymphoma Group
First international Inter-Group Study
for classical Hodgkin’s Lymphoma in Children and Adolescents
Summary
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EudraCT number |
2006-000995-33 |
Trial protocol |
DE CZ GB SE AT FR IE ES DK PL BE NL SI |
Global end of trial date |
30 Oct 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Jun 2021
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First version publication date |
10 Jun 2021
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Other versions |
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Summary report(s) |
Final report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
EuroNet-PHL-C1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Martin-Luther-University of Halle-Wittenberg
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Sponsor organisation address |
Magdeburger Str. 27, Halle (Saale), Germany, 06097
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Public contact |
Prof Dr Dieter Körholz
(Coordinating chairperson), UK Giessen und Marburg GmbH; Standort Giessen - Zentrum f. Kinderheilkunde u. Jugendmedizin, Dieter.Koerholz@paediat.med.uni-giessen.de
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Scientific contact |
Prof Dr Dieter Körholz
(Coordinating chairperson), UK Giessen und Marburg GmbH; Standort Giessen - Zentrum f. Kinderheilkunde u. Jugendmedizin, Dieter.Koerholz@paediat.med.uni-giessen.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Jul 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Oct 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Oct 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
1. Are 5 year event free survival (EFS) rate estimates in patients with adequate response after 2 OEPA treated without radiotherapy consistent with a target EFS rate of 90% in all treatment groups?
2. Can Procarbazine be safely replaced by Dacarbazine in therapy groups TG-2 and TG-3 without a deterioration of EFS (randomised comparison of COPDAC and COPP)?
3. Description of treatment outcome to a standardised risk adapted relapse strategy
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Protection of trial subjects |
Patients werde closely monitored by the trating staff with regard to safety during the course of the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Jan 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 33
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Country: Number of subjects enrolled |
Norway: 39
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Country: Number of subjects enrolled |
Poland: 98
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Country: Number of subjects enrolled |
Slovenia: 2
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Country: Number of subjects enrolled |
Spain: 105
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Country: Number of subjects enrolled |
Sweden: 56
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Country: Number of subjects enrolled |
United Kingdom: 289
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Country: Number of subjects enrolled |
Austria: 87
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Country: Number of subjects enrolled |
Belgium: 24
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Country: Number of subjects enrolled |
Czechia: 52
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Country: Number of subjects enrolled |
Denmark: 16
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Country: Number of subjects enrolled |
France: 487
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Country: Number of subjects enrolled |
Germany: 693
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Country: Number of subjects enrolled |
Ireland: 41
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Country: Number of subjects enrolled |
Slovakia: 35
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Country: Number of subjects enrolled |
Switzerland: 45
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Worldwide total number of subjects |
2102
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EEA total number of subjects |
1768
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
455
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Adolescents (12-17 years) |
1647
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Within this clinical trial N=2131 patients have been recruited in 188 trial centres in 16 European countries. The first patient within this clinical trial has been recruited on 2007-01-31, the last patient on 2013-01-29. Accrual to the study closed on 2013-01-29. | ||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Screening included: confirmation of the diagnosis by the local pathologist; FDG-PET scan before start of treatment; confirmation of local pathology result by reference pathologist; medical history; previous and concomitant disease status; clinical, laboratory and functional examinations; pubertal assessment, if appl. | ||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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TG-1 | ||||||||||||||||||||||||||||
Arm description |
TG-1 (treatment group 1): patients of stages I A/B and II A without bulk>=200 ml and without ESR>=30mm/hr All patients receive two cycles of OEPA. Patients in TG-1 with adequate response (response groups AR1 and AR2) receive no further therapy. Patients with inadequate response (IR and IRU) receive involved field radiotherapy . | ||||||||||||||||||||||||||||
Arm type |
stratification group | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Prednisone/prednisolone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
OEPA scheme
Prednisone/prednisolone
60 mg/m2/day p.o. divided into 3 doses
day 1 – 15
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Investigational medicinal product name |
Vincristine sulphate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
OEPA scheme
Vincristine
1.5 mg/m2 i.v., max. SD 2 mg
day 1 + 8 + 15
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Investigational medicinal product name |
Doxorubicine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
OEPA scheme
Doxorubicine
40 mg/m2 as 1-6 hour infusion
day 1 + 15
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Investigational medicinal product name |
Etoposide/Etopophos
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
OEPA scheme
Etoposide/Etopophos
125 mg/m² as 1-2 hour infusion
day 1 – 5
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Arm title
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TG-2 | ||||||||||||||||||||||||||||
Arm description |
TG-2 (treatment group 2): patients of stages IEA/B, IIEA, II B or III A and patients of stages I A/B and II A with bulk>=200 ml and/or ESR>=30mm/hr All patients receive two cycles of OEPA. After initial staging and assignment to treatment groups 2 or 3, patients are randomised between COPP and COPDAC. Following completion of 2 cycles of OEPA and after early response assessment including FDG-PET, patients in TG-2 receive two cycles, patients in TG-3 four cycles of either COPP or COPDAC. Patients in TG-2 / TG-3 with adequate response in early response assessment (response groups AR1 and AR2) receive no radiotherapy. | ||||||||||||||||||||||||||||
Arm type |
stratification group | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Procarbazine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
COPP scheme
Procarbazine
100 mg/m²/day, p.o. divided into 2 – 3 doses
day 1 – 15
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Investigational medicinal product name |
Cyclophosphamide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
COPP / COPDAC scheme
Cyclophosphamide
500 mg/m2, 60-min. inf.
day 1 + 8
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Investigational medicinal product name |
Dacarbazine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
COPDAC scheme
Dacarbazine
250 mg/m2 as 15 - 30-min. inf.
day 1 – 3
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Investigational medicinal product name |
Prednisone/prednisolone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
OEPA scheme
Prednisone/prednisolone
60 mg/m2/day p.o. divided into 3 doses
day 1 – 15
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Investigational medicinal product name |
Vincristine sulphate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
OEPA scheme
Vincristine
1.5 mg/m2 i.v., max. SD 2 mg
day 1 + 8 + 15
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Investigational medicinal product name |
Doxorubicine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
OEPA scheme
Doxorubicine
40 mg/m2 as 1-6 hour infusion
day 1 + 15
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Investigational medicinal product name |
Etoposide/Etopophos
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
OEPA scheme
Etoposide/Etopophos
125 mg/m² as 1-2 hour infusion
day 1 – 5
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Arm title
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TG-3 | ||||||||||||||||||||||||||||
Arm description |
TG-3 (treatment group 3): patients of stages IIEB, IIIEA/B, III B or IV A/B All patients receive two cycles of OEPA. After initial staging and assignment to treatment groups 2 or 3, patients are randomised between COPP and COPDAC. Following completion of 2 cycles of OEPA and after early response assessment including FDG-PET, patients in TG-2 receive two cycles, patients in TG-3 four cycles of either COPP or COPDAC. Patients in TG-2 / TG-3 with adequate response in early response assessment (response groups AR1 and AR2) receive no radiotherapy. | ||||||||||||||||||||||||||||
Arm type |
stratification group | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Procarbazine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
COPP scheme
Procarbazine
100 mg/m²/day, p.o. divided into 2 – 3 doses
day 1 – 15
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Investigational medicinal product name |
Cyclophosphamide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
COPP / COPDAC scheme
Cyclophosphamide
500 mg/m2, 60-min. inf.
day 1 + 8
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Investigational medicinal product name |
Dacarbazine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
COPDAC scheme
Dacarbazine
250 mg/m2 as 15 - 30-min. inf.
day 1 – 3
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Investigational medicinal product name |
Prednisone/prednisolone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
OEPA scheme
Prednisone/prednisolone
60 mg/m2/day p.o. divided into 3 doses
day 1 – 15
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Investigational medicinal product name |
Vincristine sulphate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
OEPA scheme
Vincristine
1.5 mg/m2 i.v., max. SD 2 mg
day 1 + 8 + 15
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Investigational medicinal product name |
Doxorubicine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
OEPA scheme
Doxorubicine
40 mg/m2 as 1-6 hour infusion
day 1 + 15
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Investigational medicinal product name |
Etoposide/Etopophos
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
OEPA scheme
Etoposide/Etopophos
125 mg/m² as 1-2 hour infusion
day 1 – 5
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Baseline characteristics reporting groups
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Reporting group title |
TG-1
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Reporting group description |
TG-1 (treatment group 1): patients of stages I A/B and II A without bulk>=200 ml and without ESR>=30mm/hr All patients receive two cycles of OEPA. Patients in TG-1 with adequate response (response groups AR1 and AR2) receive no further therapy. Patients with inadequate response (IR and IRU) receive involved field radiotherapy . | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
TG-2
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Reporting group description |
TG-2 (treatment group 2): patients of stages IEA/B, IIEA, II B or III A and patients of stages I A/B and II A with bulk>=200 ml and/or ESR>=30mm/hr All patients receive two cycles of OEPA. After initial staging and assignment to treatment groups 2 or 3, patients are randomised between COPP and COPDAC. Following completion of 2 cycles of OEPA and after early response assessment including FDG-PET, patients in TG-2 receive two cycles, patients in TG-3 four cycles of either COPP or COPDAC. Patients in TG-2 / TG-3 with adequate response in early response assessment (response groups AR1 and AR2) receive no radiotherapy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
TG-3
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Reporting group description |
TG-3 (treatment group 3): patients of stages IIEB, IIIEA/B, III B or IV A/B All patients receive two cycles of OEPA. After initial staging and assignment to treatment groups 2 or 3, patients are randomised between COPP and COPDAC. Following completion of 2 cycles of OEPA and after early response assessment including FDG-PET, patients in TG-2 receive two cycles, patients in TG-3 four cycles of either COPP or COPDAC. Patients in TG-2 / TG-3 with adequate response in early response assessment (response groups AR1 and AR2) receive no radiotherapy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
TG-1
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Reporting group description |
TG-1 (treatment group 1): patients of stages I A/B and II A without bulk>=200 ml and without ESR>=30mm/hr All patients receive two cycles of OEPA. Patients in TG-1 with adequate response (response groups AR1 and AR2) receive no further therapy. Patients with inadequate response (IR and IRU) receive involved field radiotherapy . | ||
Reporting group title |
TG-2
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Reporting group description |
TG-2 (treatment group 2): patients of stages IEA/B, IIEA, II B or III A and patients of stages I A/B and II A with bulk>=200 ml and/or ESR>=30mm/hr All patients receive two cycles of OEPA. After initial staging and assignment to treatment groups 2 or 3, patients are randomised between COPP and COPDAC. Following completion of 2 cycles of OEPA and after early response assessment including FDG-PET, patients in TG-2 receive two cycles, patients in TG-3 four cycles of either COPP or COPDAC. Patients in TG-2 / TG-3 with adequate response in early response assessment (response groups AR1 and AR2) receive no radiotherapy. | ||
Reporting group title |
TG-3
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Reporting group description |
TG-3 (treatment group 3): patients of stages IIEB, IIIEA/B, III B or IV A/B All patients receive two cycles of OEPA. After initial staging and assignment to treatment groups 2 or 3, patients are randomised between COPP and COPDAC. Following completion of 2 cycles of OEPA and after early response assessment including FDG-PET, patients in TG-2 receive two cycles, patients in TG-3 four cycles of either COPP or COPDAC. Patients in TG-2 / TG-3 with adequate response in early response assessment (response groups AR1 and AR2) receive no radiotherapy. |
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End point title |
Event free survival (EFS) [1] | ||||||||||||||||
End point description |
EFS = time from registration until the first of the following events:
- progression/relapse of disease
- occurrence of a secondary malignancy
- death by any cause
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End point type |
Primary
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End point timeframe |
60 months
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See attached final trial report |
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No statistical analyses for this end point |
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End point title |
Overall Survival | ||||||||||||||||
End point description |
Overall survival (OS) = time period from registration until death of any cause
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End point type |
Secondary
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End point timeframe |
60 months
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
3 months after application of last trial therapy
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
22.1
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Frequency threshold for reporting non-serious adverse events: 5% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: See attached final trial report |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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10 Sep 2007 |
1. Data of the interim analysis of the GPOH-HD2002 pilot study support that COPDAC is an effective and safe treatment option. Relevant safety information is updated.
2. Treatment of study patients who refuse randomisation. (In the event of refusal of randomisation between COPP and COPDAC the recommendation of the trial chairpersons is that COPP is considered as the standard arm. In these situations these patients will remain on the study. These patients will be informative concerning the STAR question and add to the safety data. Patients should not be treated on the COPDAC arm outside the study.)
3. SAE reporting: Time horizon and clarification in order avoid unnecessary SAE – reporting. (SAE reporting is restricted to events occurring within 3 month after the end of the study treatment; addition of expected toxicities for each IMP and RT)
4. Administrative data (update of contact data, correction of typos) |
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17 Nov 2009 |
1. Clarification of discrepancies between patient information and informed consent declaration concerning time of archiving
2. Change of members in the central review team and in the panel of referenpathologists.
3. Title of patient information and informed consent for relapse treatment is adjusted to the protocol. The inclusion criteria do not contain an age limit for patients with relapse of childhood and adolescent Hodgkin`s Lymphoma
4. Clarification in patient information for primary and relapse treatment that depending on the treatment center either prednisone or prednisolon will be used as prescribed in the final version of the treatment protocol
5. Clarification of antibacterial prophylaxis since the use of these drugs is differently handled in the various countries and institutions. However, this will not affect the study results, since all patients will receive a necessary prophylaxis.
6. The protocol prescribes either Prednisone or Prednisolone. In the abbreviation section only prednisone was listed, Therefore prednisolone was added for formal correctness.
7. Administrative data (update of contact data)
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22 Feb 2012 |
1. Stop randomisation COPP vs COPDAC: Further to a Clinical Board Meeting of EuroNet-PHL and the Annual EuroNet-PHL Clinicians Meeting (from 09.02.2012 to 11.02.2012), a decision was made to end the randomisation between COPP and COPDAC for eligible Patients in the EuroNet-PHL-C1 trial. This decision was made on the basis of the results of the second interim data analysis which showed emerging evidence that COPP and COPDAC are similarly efficacious. In view of the evidence that emerged from the interim data analysis of EuroNet PHL-C1 the Clinical Board and associated parties saw a change in the risk-benefit assessment for the trial and decided that randomisation should be stopped on 13.02.2012. Although the data was immature, it was clear that the sample size was sufficient to answer the randomised question on efficacy and that furthermore it was essential to avoid the potentially detrimental effects of COPP on male fertility. All Patients in EuroNet-PHL-C1 (in TG-2 and TG-3) should now receive COPDAC. The trial remained open to recruitment (outside of Germany) because that data was required to fully answer the other important questions in the protocol relating to the STAR approach to treatment and whether it is safe to omit radiotherapy.
2. Administrative data: Update of contact data |
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13 Apr 2015 |
1. Addition of global scientific side projects:
a) DETERMINATION OF ANTI MULLERIAN AND OTHER GONADAL HORMONES IN FEMALE PATIENTS OF THE EURONET-PHL-C1 PATIENTS; b) QUALITY CONTROL IN RADIOTHERAPY; c) INCIDENCE OF OSTEONECROSES IN CHILDREN AND ADOLESCENTS TREATED WITHIN THE EURONET-PHL-C1 TRIAL
2. Addition of country-specific scientific side projects:
a) IDENTIFICATION OF A PROGNOSTIC GENE EXPRESSION SIGNATURE IN PEDIATRIC HODGKIN’S LYMPHOMA IN CONTEXT OF THE EURONET-PHL-C1 TRIAL; b) IDENTIFICATION OF DISTINCTIVE PATHOLOGIC FEATURES OF PEDIATRIC HODGKIN’S LYMPHOMAS WITH ABNORMAL CHEMO RESPONSE IN CONTEXT OF THE EURONET-PHL-C1 TRIAL c) ASSESSMENT OF LATE EFFECTS IN PATIENTS TREATED ACCORDING TO EURONET-PHL-C1 |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |