NCT02797717Recruiting
Treatment for Classical Hodgkin Lymphoma in Children and Adolescents
An International, Multicentre, Randomised Controlled Trial. Treatment for Classical Hodgkin Lymphoma in Children and Adolescents Standard Treatment (Chemotherapy and RT) Compared With Experimental Treatment (Chemotherapy Without RT or Restricted to RT)
Source: ClinicalTrials.gov · Last updated 14 Jun 2016 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Reduction of the indication for radiotherapy (RT) in newly diagnosed patients with classical Hodgkins lymphoma without compromising cure rates. Investigation of a chemotherapy intensification randomisation in intermediate and advanced classical Hodgkins lymphoma patients to compensate for reduction in RT.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2200 (estimated)
- First submitted
- 12 Apr 2016
- Start date
- Nov 2015
- Primary completion date
- Dec 2022
- Lead sponsor
- GALIA AVRAHAMI
- Diseases
- Childhood cancers
- NCT number
- NCT02797717
What you commit to
- Study type: Interventional
- Planned participants: 2200
- From Nov 2015 to the primary completion date, Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior chemotherapy or radiotherapy for other malignancies
- pre-treatment of Hodgkin's lymphoma (except for steroid pre-phase to a maximum of 7-10 days for emergency treatment of a large mediastinal tumour).
- severe concomitant diseases (e.g. immune deficiency syndrome)
- 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
Other illness
- other (simultaneous) malignancies
- contraindication or known hypersensitivity to study drugs
- known HIV-positivity
Lab values
- diagnosis of lymphocyte-predominant Hodgkin's lymphoma
Other
- residence outside the participating countries where long term follow-up cannot be guaranteed
- pregnancy and / or lactation
Who the study is looking for
- 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 Australia, France, Italy, New Zealand and United Kingdom 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
Age in the registry: 1 month to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.