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EuroNet-PHL-C2
Stand 13.10.2020 22:46

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

NCT-Nummer:

[--]*

EudraCT-Nummer:

2012-004053-88 ( EU Clinical Trials Register )

Studienstatus:

Läuft (Rekrutierung offen)

Rekrutierung:

seit 16 Sep 2015

Studiendesign:

Phase: Therapieoptimierung , Studientyp: Therapeutisch , IIT: Ja , Multizentrisch , International

Therapielinie:

Erstlinie

Patientenalter:

Under 18: Children (2-11years), Adolescents (12-17 years) EU Clinical Trials Register Stand: 16.06.2016 16:36

Indikation:

Morbus Hodgkin

Anatomic Site:

Lymphoma

Klinik / Organisation:

Kinderklinik und Poliklinik ( Universitätsklinikum Würzburg )

Sponsor:

Justus-Liebig-Universität Gießen

LKP:

Prof. Dr. Dieter Körholz, Justus-Liebig-Universität Gießen

Hauptprüfer:

Herr Prof. Dr. Paul-Gerhardt Schlegel (Universitätsklinikum Würzburg)

Stellvertreter:

Herr Prof. Dr. Matthias Eyrich (Universitätsklinikum Würzburg)
• 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
• 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