Clinical trial NCT02797717: Treatment for Classical Hodgkin Lymphoma in Children and Adolescents
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Classical Hodgkins Lymphoma in Children and Adolescents.
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: University of Giessen
First posted: 2016-06-13
Enrollment: 2200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. histologically confirmed primary diagnosis of classical Hodgkin's lymphoma.
2. 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.
3. written informed consent of the patient and/or the patient's parents or guardian according to national laws.
4. negative pregnancy test within 2 weeks prior to starting treatment for female patients with childbearing potential

Exclusion Criteria: (Patients with one or more of the following criterion are excluded)

1. prior chemotherapy or radiotherapy for other malignancies
2. 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).
3. diagnosis of lymphocyte-predominant Hodgkin's lymphoma
4. other (simultaneous) malignancies
5. contraindication or known hypersensitivity to study drugs
6. severe concomitant diseases (e.g. immune deficiency syndrome)
7. known HIV-positivity
8. residence outside the participating countries where long term follow-up cannot be guaranteed
9. pregnancy and / or lactation
10. patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment
11. 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

Primary outcomes:
measure: Increase event free survival rate from 88% to 93%
timeFrame: Will be assessed once a year up to 5 years after end of treatment.
Secondary outcomes:
measure: comparison of haematotoxicity between arm A and arm B
timeFrame: Will be assessed in day 0,day 8,day 11,day 17 and day 21 of each cycle
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schneider children's medical center
Study officials:
affiliation: Universit.tsklinikum Giessen
name: Dieter K.rholz, Prof. Dr.
role: STUDY_CHAIR
affiliation: Schneider children medical center,Kaplan 14 Petach-Tikva,Israel
name: Galia Avrahami, MD
role: PRINCIPAL_INVESTIGATOR
References: