EuroNet-Paediatric Hodgkin*s Lymphoma Group ;Second International Inter-Group Study for Classical Hodgkin*s Lymphoma in Children and Adolescents
- Conditions
- Classical Hodgkins Lymphoma10025319
- Registration Number
- NL-OMON53041
- Lead Sponsor
- Justus-Liebig-University Giessen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 124
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To increase event-free survival (EFS) in ERA PET-negative TL-2 and TL-3<br /><br>patients without radiotherapy by using intensified consolidation chemotherapy<br /><br>(DECOPDAC-21).<br /><br>- To demonstrate in ERA PET-positive TL-2 and TL-3 patients that the<br /><br>combination of intensified consolidation chemotherapy (DECOPDAC-21) plus<br /><br>restricted field radiotherapy based on the LRA is comparable to the standard<br /><br>consolidation chemotherapy (COPDAC-28) plus standard involved node<br /><br>radiotherapy. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Evaluation of haematotoxicity during different chemotherapy regimens.<br /><br>- For ERA positive patients to compare the late response assessment positivity<br /><br>rates after consolidation chemotherapy with COPDAC-28 or DECOPDAC-21.<br /><br><br /><br>Outcome measures<br /><br>The primary outcome is event-free survival (EFS) defined as time from start of<br /><br>treatment until the first of the following events:<br /><br>• progression/relapse of disease<br /><br>• secondary malignancy<br /><br>• death from any cause.<br /><br><br /><br>Secondary outcomes include efficacy, quality and safety endpoints. </p><br>