EUCTR2012-004053-88-PLActive, not recruitingPhase 1
EuroNet-Paediatric Hodgkin’s Lymphoma Group Second International Inter-Group Studyfor Classical Hodgkin’s Lymphoma in Children and Adolescents - EuroNet-PHL-C2
Jagiellonian University Medical College0 sites2,200 target enrollmentStarted: February 22, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 2,200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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