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)
This study is testing if stronger combinations of chemotherapy can help children and teens with classical Hodgkin lymphoma get better without needing as much radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2200 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Petah Tikva) |
| Trial ID | NCT02797717 on ClinicalTrials.gov |
What this trial studies
This study aims to reduce the use of radiotherapy in newly diagnosed children and adolescents with classical Hodgkin lymphoma while maintaining high cure rates. It investigates the intensification of chemotherapy regimens for patients with intermediate and advanced stages of the disease to compensate for the reduced reliance on radiotherapy. The study involves a randomization process to evaluate the effectiveness of different chemotherapy combinations, including Vincristine, Etoposide, Prednisone, and Doxorubicin.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents under 18 years old with a confirmed diagnosis of classical Hodgkin lymphoma.
Not a fit: Patients who have previously received chemotherapy or radiotherapy for other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less exposure to radiotherapy for young patients, minimizing long-term side effects while still achieving effective treatment outcomes.
How similar studies have performed: Other studies have shown promise in reducing radiotherapy in similar patient populations, indicating that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Petah Tikva
- Schneider children's medical center — Petah Tikva, Israel (Recruiting)
Study contacts
- Principal investigator: Galia Avrahami, MD — Schneider children medical center,Kaplan 14 Petach-Tikva,Israel
- Study coordinator: Galia Avrahami, MD
- Email: Galia2@clalit.org.il
- Phone: 972-3-9253356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.