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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02684708




Registration number
NCT02684708
Ethics application status
Date submitted
19/11/2015
Date registered
18/02/2016

Titles & IDs
Public title
Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
Scientific title
European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
Secondary ID [1] 0 0
EuroNet-PHL-C2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Classical Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cyclophosphamide, vincristine, prednisone, dacarbazine
Treatment: Drugs - cyclo, vcr, pred, dacarb,etop and doxo

Active comparator: COPDAC-28 - cyclophosphamide, vincristine, prednisone, dacarbazine; cyclophosphamide 500 mg/m2, per infusion on day 1 + 8; vincristine 1.5 mg/m2 intravenously (capping dose 2 mg) on day 1 + 8 and prednisone 40 mg/m2/day by mouth divided into 3 doses (capping dose 80 mg/day) on day 1 - 15 and dacarbazine 250 mg/m2 infusion on day 1 - 3

Experimental: DECOPDAC-21 - patients with intermediate and advanced stages will be randomized after the induction therapy to receive either COPDAC-28 standard consolidation or the intensified DECOPDAC-21. cyclophosphamide dose augmented to 625 mg/m2 and adminstered per infusion on day 1 and day 2; vincristine dose not changed; prednisone 40 mg/m2/day by mouth on day 1 - 8 (no capping dose prescribed), i.e. dose-reduction; dacarbazine dose not changed; etoposide infusion100 mg/m2/day on day 1 - 3 and doxorubicine 25 mg/m2 per infusion on day 1as additional drugs in comparison to active comparator; cycle is administered as 21 days instead of 28 days-cycle for intensification


Treatment: Drugs: cyclophosphamide, vincristine, prednisone, dacarbazine
28-day chemotherapy cycle

Treatment: Drugs: cyclo, vcr, pred, dacarb,etop and doxo
21-day chemotherapy cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free survival
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Progression-free survival
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
CTC (common toxicity criteria) grading during any individual treatment element including assessment of osteonecrosis
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Time from day of PET imaging until decision on response category at ERA or LRA, respectively
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Time from last day of chemotherapy to first day of radiotherapy in patients with radiotherapy indication
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
Time from last dose of prednisone/prednisolone in OEPA to start of the first consolidation cycle
Timepoint [6] 0 0
5 years

Eligibility
Key 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
Minimum age
No limit
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
2200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Children's Hospital and Monash Medical Centre Royal Children's Hospital - Victoria Park
Recruitment postcode(s) [1] 0 0
3052 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Czechia
State/province [3] 0 0
Prague
Country [4] 0 0
Denmark
State/province [4] 0 0
Copenhagen
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Germany
State/province [6] 0 0
Giessen
Country [7] 0 0
Ireland
State/province [7] 0 0
Dublin
Country [8] 0 0
Israel
State/province [8] 0 0
Petach Tikva
Country [9] 0 0
Italy
State/province [9] 0 0
Aviano
Country [10] 0 0
Netherlands
State/province [10] 0 0
Utrecht
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland
Country [12] 0 0
Norway
State/province [12] 0 0
Oslo
Country [13] 0 0
Poland
State/province [13] 0 0
Kraków
Country [14] 0 0
Slovakia
State/province [14] 0 0
Bratislava
Country [15] 0 0
Spain
State/province [15] 0 0
Sevilla
Country [16] 0 0
Sweden
State/province [16] 0 0
Uppsala
Country [17] 0 0
Switzerland
State/province [17] 0 0
Lausanne
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
University of Giessen
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Deutsche Krebshilfe e.V., Bonn (Germany)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Euronet Worldwide
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dieter Koerholz, MD
Address 0 0
Justus-Liebig University of Giessen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02684708