Treatment for pediatric Hodgkin lymphoma with reduced chemotherapy and radiation
Non Randomized, Multicenter, Prospective Pediatric Hodgkin Lymphoma Treatment Trial Stratified According to Initial Risk Factors and Response to Chemotherapy, Reduced Cumulative Doses of Antineoplastic Agents and Radiotherapy.
This study is testing a new way to treat children with Hodgkin lymphoma by using less chemotherapy and radiation to see if it can still help them get better while lowering the chances of long-term side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Hospital JP Garrahan Government |
| Drugs / interventions | chemotherapy, radiation, doxorubicin |
| Locations | 1 site (Buenos Aires, Buenos Aires F.D.) |
| Trial ID | NCT03500133 on ClinicalTrials.gov |
What this trial studies
This trial aims to treat pediatric patients with newly diagnosed classical Hodgkin lymphoma by administering a tailored therapy that minimizes chemotherapy and radiation exposure. Patients are stratified into low, intermediate, and high-risk groups based on initial staging, followed by two courses of chemotherapy. Disease response is assessed early, allowing rapid responders to receive less treatment, while those who do not achieve complete remission may receive low-dose radiation. The goal is to achieve long-lasting remission while reducing the risk of late effects from treatment.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 2 to 18 years with newly diagnosed classical Hodgkin lymphoma.
Not a fit: Patients with lymphocyte predominant nodular Hodgkin lymphoma or those with immunodeficiencies may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this approach could lead to effective treatment of pediatric Hodgkin lymphoma with fewer long-term side effects.
How similar studies have performed: Previous studies have shown promise in reducing treatment intensity for Hodgkin lymphoma, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histopathological diagnosis of classical Hodgkin lymphoma. * Normal renal, hepatic, pulmonary and metabolic function standards. * Informed consent signed by patient and/or legal caretakers. Exclusion Criteria: * Lymphocyte predominant nodular Hodgkin lymphoma * Any form of immunodeficiency before diagnosis. (primary immunodeficiencies, trasplant recipients or immunosuppressive therapies of any kind including corticoid therapies during 28 days before diagnosis). * Pregnancy and breastfeeding period. * Sexually active female patients who do not accept an effective contraceptive method during therapy. * Positive HIV serology. * Penfigus or hepatic ductopenia. * Hodgkin lymphoma as a secondary malignant disease.
Where this trial is running
Buenos Aires, Buenos Aires F.D.
- Hospital JP Garrahan — Buenos Aires, Buenos Aires F.D., Argentina (Recruiting)
Study contacts
- Study coordinator: Pedro A Zubizarreta, MD
- Email: pedro.zubizarreta@hotmail.com
- Phone: +541131207433
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.