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NCT02684708

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

Datenbasis: WHO (Import vom 18.04.2024)
Geändert: 13.03.2024, 01:00
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Classical Hodgkin Lymphoma

Interventions (Datenquelle: WHO)

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

Inclusion/Exclusion Criteria (Datenquelle: 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

Weitere Angaben zur Studie im WHO-Primärregister

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

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02684708
Weitere Informationen zur Studie

Datum der Studienregistrierung

19.11.2015

Rekrutierungsstatus

Active, not recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

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

Studientyp (Datenquelle: WHO)

Interventional

Design der Studie (Datenquelle: WHO)

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

Phase (Datenquelle: WHO)

Phase 3

Primäre Endpunkte (Datenquelle: WHO)

Event-free survival

Sekundäre Endpunkte (Datenquelle: 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

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

noch keine Angaben verfügbar

Link zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

No

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

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

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Dieter Koerholz, MD
Justus-Liebig University of Giessen

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Dieter Koerholz, MD
Justus-Liebig University of Giessen

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

EuroNet-PHL-C2
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