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NCT02684708

Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents

Data source: WHO (Imported from 03.05.2024)
Changed: Mar 13, 2024, 1:00 AM
Disease category:

Health conditions (Data source: WHO)

Classical Hodgkin Lymphoma

Interventions (Data source: WHO)

Drug: cyclophosphamide, vincristine, prednisone, dacarbazine;Drug: cyclo, vcr, pred, dacarb,etop and doxo

Inclusion/Exclusion Criteria (Data source: WHO)

Gender: All
Maximum age: 25 Years
Minimum age: N/A

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

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 in WHO primary registry

https://clinicaltrials.gov/ct2/show/NCT02684708

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02684708
Further information on trial

Date trial registered

Nov 19, 2015

Recruitment status

Active, not recruiting

Academic title (Data source: WHO)

European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

Event-free survival

Secundary end point (Data source: WHO)

Overall survival;Progression-free survival;CTC (common toxicity criteria) grading during any individual treatment element including assessment of osteonecrosis;Time from day of PET imaging until decision on response category at ERA or LRA, respectively;Time from last day of chemotherapy to first day of radiotherapy in patients with radiotherapy indication;Time from last dose of prednisone/prednisolone in OEPA to start of the first consolidation cycle

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

No

Trial sites

Countries (Data source: WHO)

Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom

Contact for further information on the trial

Contact for general information (Data source: WHO)

Dieter Koerholz, MD
Justus-Liebig University of Giessen

Contact for scientific information (Data source: WHO)

Dieter Koerholz, MD
Justus-Liebig University of Giessen

Further trial identification numbers

Secondary ID (Data source: WHO)

EuroNet-PHL-C2
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