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SNCTP000001998 | EUCTR2012-004053-88 | BASEC2016-01180

Zweite internationale Studie des klassischen Hodgkins Lymphom bei Kindern und Jugendlichen (EuroNet-PHL-C2)

Data source: BASEC (Imported from 28.03.2024), WHO (Imported from 20.03.2024)
Changed: Jan 10, 2024, 9:27 AM
Disease category:

Brief description of trial (Data source: BASEC)

In den letzten 25 Jahren konnte man erreichen, dass mit der Behandlung, die auch in dieser Studie vorgesehen ist, fast alle Patienten mit einem Hodgkin-Lymphom geheilt werden können. In dieser Studie zur Therapie des Hodgkin Lymphoms soll - basierend auf den Erfahrungen der Vorläuferstudie EuroNet-PHL-C1 - geprüft werden, ob aufgrund folgender Änderungen die Heilungsraten weiter verbessert und/oder die Risiken für Langzeitfolgen weiter vermindert werden können: - Verringerung der Zahl von Patienten mit Zweitkrebserkrankungen durch gezielte Vermeidung der Bestrahlungsbehandlung - Vermeidung der Unfruchtbarkeit beim Knaben/männlichen Jugendlichen durch Verzicht auf das Medikament Procarbazin - Weitere Verbesserung der Heilungsraten durch Intensivierung der Chemotherapie (Vergleich der Wirkung von COPDAC-28 Chemotherapie (etablierter Standard) mit DECOPDAC-21 Chemotherapie (neu) bei einem Teil der Patienten (Therapielevel 2 und 3) - Veränderungen bei der Durchführung der Bestrahlungstherapie Durch die Behandlung erkrankter Kinder und Jugendlicher im Rahmen genau definierter Therapiestudien wird flächendeckend eine qualitätsgesicherte Behandlung und ein einheitlicher Therapiestandard für eine seltene Erkrankung im Kindes- und Jugendalter, unabhängig von der Erfahrung und dem Versorgungsstandard der behandelnden Klinik, gewährleistet. Hierzu wurden in den vergangenen dreissig Jahren in Deutschland über zwanzig Studienzentralen für die verschiedenen Krebserkrankungen bei Kindern und Jugendlichen eingerichtet. Die EuroNet-PHL-C2-Studienzentrale in Giessen bzw. Halle/Leipzig, ist für die Optimierung der Behandlung des Hodgkin Lymphoms zuständig und erfüllt hierbei die folgenden Aufgaben: - zentrale Begutachtung aller klinischen und apparativen Untersuchungsbefunde (ärztliche Zweitmeinung) und - Beratung der teilnehmenden Kliniken bei allen medizinischen Problemen, die im Zusammenhang mit der Behandlung des Hodgkin Lymphoms bei einem individuellen Patienten auftreten können.

Health conditions investigated(Data source: BASEC)

Klassisches Hodgkin Lymphom bei Kindern und Jugendlichen

Health conditions (Data source: WHO)

Hodgkin lymphoma in children and adolescents;Therapeutic area: Diseases [C] - Cancer [C04]

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Die Patienten werden risikoadaptiert in 3 Behandlungsgruppen (Therapielevels=TL) eingeteilt.
• TL-1: Niedriges Ausbreitungsstadium
• TL-2: Mittleres Ausbreitungsstadium
• TL-3: Fortgeschrittenes Ausbreitungsstadium
Die Patienten der TL-2 und TL-3 werden randomisiert: Standard COPDAC-28 vs. intensivierte Chemotherapie DECOPDAC-21. Die Patienten der TL-1 werden nicht randomisiert.

Interventions (Data source: WHO)


Product Name: Vincristine
Product Code: VCR
Pharmaceutical Form: Solution for injection
INN or Proposed INN: VINCRISTINE
CAS Number: 57-22-7
Current Sponsor code: VCR

Product Name: Etoposide, Etopophos
Product Code: ETO
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: ETOPOSIDE
Current Sponsor code: ETOP
Other descriptive name: ETOPOSIDE

Trade Name: Prednison
Product Name: Prednisone
Product Code: PRED
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
Current Sponsor code: PRED
Other descriptive name: PREDNISONE

Product Name: Doxorubicin
Product Code: DOX
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214-92-8

Product Name: Cyclophosphamide
Product Code: CYC
Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion
INN or Proposed INN: CYCLOPHOSPHAMIDE
CAS Number: 50-18-0
Current Sponsor code: CYC

Product Name: Dacarbazine
Product Code: DAC
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: DACARBAZINE
CAS Number: 4342-03-4
Current Sponsor code: DAC

Product Name: Vinblastine
Product Code: VBL
Pharmaceutical Form: Solution for injection
INN or Proposed INN: VINBLASTINE
CAS Number: 865-21-4
Current Sponsor code: VBL

Product Name: Prednisolone
Product Code: PREDNISOLONE
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE

Criteria for participation in trial (Data source: BASEC)

• Histologisch bestätigtes primäres klassisches Hodgkin Lymphom
• Patienten unter 18 Jahren
• Signierte Einwilligungserklärung des Patienten/Eltern
• Negativer Schwangerschaftstest

Exclusion criteria (Data source: BASEC)

• Vorgängige Chemotherapie oder Strahlentherapie aufgrund einer anderen Krebserkrankung
• Vorgängige Behandlung des Hodgkin Lymphoms
• Lymphozyten prädominantes Hodgkin Lymphom
• Andere Krebserkrankung
• Kontraindikation oder bekannte Überempfindlichkeit auf Studienmedikament
• Schwerwiegende andere Krankheit(en)
• HIV-positiv
• Wohnort ausserhalb der Schweiz, wo die Langzeit-Nachbeobachtung nicht möglich ist
• Schwangerschaft/Stillen
• Sexuell aktive Patienten, die nicht während der Studie und ein Monat nach Behandlung verhüten wollen
• Teilnahme in einer anderen Therapiestudie

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria:
•histologically confirmed primary diagnosis of classical Hodgkin’s lymphoma
•patients under 18 years of age on the date of written informed consent. In specialized Teenage and Young Adult (TYA) units in France, Italy and UK patients up to under 25 years of age can also be enrolled. Lower age limits will be country specific according to national laws or formal insurance requirements that may preclude very young patients.
•written informed consent of the patient and/or the patient’s parents or guardian according to national laws
•negative pregnancy test within 2 weeks prior to starting treatment for female patients with childbearing potential

Are the trial subjects under 18? yes
Number of subjects for this age range: 2200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•prior chemotherapy or radiotherapy for other malignancies
•pre-treatment of Hodgkin’s lymphoma (except for 7-10 days steroid pre-phase of a large mediastinal tumour)
•diagnosis of lymphocyte-predominant Hodgkin’s lymphoma
•other (simultaneous) malignancies
•contraindication or known hypersensitivity to study drugs
•severe concomitant diseases (e.g. immune deficiency syndrome)
•known HIV-positivity
•residence outside the participating countries where long term follow-up cannot be guaranteed
•pregnancy and/or lactation
•patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment
•current or recent (within 30 days prior to date of written informed consent) treatment with another investigational drug or participation in another interventional clinical trial

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2012-004053-88
Further information on trial

Date trial registered

Jan 20, 2015

Incorporation of the first participant

Mar 23, 2015

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

EuroNet-Paediatric Hodgkin’s Lymphoma Group Second International Inter-Group Studyfor Classical Hodgkin’s Lymphoma in Children and Adolescents - EuroNet-PHL-C2

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: yes
Other specify the comparator: two or four intensified DECOPDAC-21 consolidation chemotherapy cycles
Number of treatment arms in the trial: 3

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): yes

Primary end point (Data source: WHO)

Main Objective: 3.4.1.1Randomised
1.To increase event-free survival in ERA(early response assessment) PET-negative intermediate and advanced stage patients (TL-2 and TL-3) without radiotherapy by using intensified consolidation chemotherapy (DECOPDAC-21).

2.To demonstrate in ERA PET-positive TL-2 and TL-3 patients that the combination of intensified consolidation chemotherapy (DECOPDAC-21) plus restricted field RT to sites that remain FDG-PET positive at the late response assessment (LRA) is comparable to the standard consolidation chemotherapy (COPDAC-28) plus standard involved node radiotherapy.

3.4.1.2Non-randomised
3.To further reduce the radiotherapy indication in early stage patients by increasing the threshold for a positive FDG PET scan at early response assessment (ERA) to Deauville 4+ while still preserving a 5 year EFS estimate at a target of 90% or above.
;Secondary Objective: 1.Evaluation of haematotoxicity by documentation of blood count courses during OEPA, COPDAC-28 and DECOPDAC-21 cycles and comparison between COPDAC-28 versus DECOPDAC-21.
2.For ERA PET-positive patients to compare the LRA PET-positivity rates after consolidation chemotherapy with COPDAC-28 or DECOPDAC-21.
;Primary end point(s): 3.5.1Primary efficacy endpoint
•Event-free survival (EFS) defined as time from start of treatment until the first of the following events:
oprogression/relapse of disease
osecondary malignancy
odeath from any cause;Timepoint(s) of evaluation of this end point: Descriptive data analyses will be performed annually checking data integrity, monitoring study performance quality endpoints as well as describing treatment related toxicities for the annual safety report.
The clinical board of EuroNet-PHL will decide on adequate measures in response to potential findings. The DMC may be consulted for independent guidance if there is a potential change in the risk-benefit analysis or lack of consensus in the clinical board.
Interim analyses on efficacy will be performed annually starting in year three after the start of accrual when a meaningful number of patients will be on study for more than one year.

Secundary end point (Data source: WHO)

Secondary end point(s): 3.5.2Secondary endpoints
•Efficacy: overall survival (OS), progression-free survival (PFS)
•Safety: CTC (common toxicity criteria) grading during any individual treatment element including assessment of osteonecrosis
•Quality:
oTime from day of PET imaging until decision on response category at ERA or LRA, respectively
oTime from last day of chemotherapy to first day of radiotherapy in patients with radiotherapy indication
oTime from last dose of prednisone/prednisolone in OEPA to start of the first consolidation cycle
oDuration of chemotherapy
oChemotherapy dose actually administered divided by scheduled total dose for each drug
oDiscontinuation or substitution rate for each drug
oTime from FDG-Injection to start of PET acquisition
oProportion of patients with enhanced FDG-uptake in brown fat under use of beta-blockers
oAverage liver FDG-uptake at staging, ERA and LRA (reproducibility)
oApplied FDG-dose in relation to the EANM paediatric dosage card recommendation
oApplied radiation dose in low dose PET-CT (tube current, tube voltage and rotation time)
oDuration of radiotherapy, radiotherapy discontinuation rate
oDelivery of radiotherapy according to protocol guidelines.;Timepoint(s) of evaluation of this end point: Descriptive data analyses will be performed annually checking data integrity, monitoring study performance quality endpoints as well as describing treatment related toxicities for the annual safety report.
The clinical board of EuroNet-PHL will decide on adequate measures in response to potential findings. The DMC may be consulted for independent guidance if there is a potential change in the risk-benefit analysis or lack of consensus in the clinical board.
Interim analyses on efficacy will be performed annually starting in year three after the start of accrual when a meaningful number of patients will be on study for more than one year.

Contact information (Data source: WHO)

Deutsch Krebshilfe e.V./Dr. Mildred Scheel Foundation

Trial results (Data source: WHO)

Results summary

EuroNet-Paediatric Hodgkin’s Lymphoma Group Second International Inter-Group Studyfor Classical Hodgkin’s Lymphoma in Children and Adolescents

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Aarau, Basel, Bellinzona, Bern, Geneva, Lausanne, Luzern, St. Gallen, Zurich

Countries (Data source: WHO)

Australia, Austria, Belgium, Czech Republic, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Dr. med. Francesco Ceppi
+41 21 314 34 89
francesco.ceppi@chuv.ch

Contact for general information (Data source: WHO)

Prof Dr Anne Uyttebroeck
Herestraat 49
UZ Leuven
003216343972
anne.uyttebroeck@uzleuven.be

Contact for scientific information (Data source: WHO)

Prof Dr Anne Uyttebroeck
Herestraat 49
UZ Leuven
003216343972
anne.uyttebroeck@uzleuven.be

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Bern

Date of authorisation by the ethics committee

17.11.2016

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2016-01180

Secondary ID (Data source: WHO)

EuroNet-PHL-C2
final
2012-004053-88-DE
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