Pediatric Hodgkin Lymphoma Treatment Trial With Low Cumulative Doses of Chemotherapy Agents and Reduced Radiation.

Recruiting now · Phase 4

Conditions studied: Pediatric Hodgkin's Disease

In brief

This trial proposes a therapy for pediatric Hodgkin lymphoma with the objective of achieving high levels of long lasting complete remission with less risk of late effects. Patients of both genders, between 2 and 18 years, with newly diagnosed classical Hodgkin lymphoma are admitted. Initial staging provides stratification in three groups: low, intermediate and high risk. An initial set of two chemotherapy courses is administered to all cases after which a new disease assessment is performed. According to disease response a final therapy group is assigned. Rapid early responders benefit from less chemotherapy. At the end of chemotherapy, radiotherapy is delivered only to patients who do not achieve a complete response. Thus therapy is tailored to initial extension and disease responsiveness. Complete responders at the end of chemotherapy do not receive radiotherapy. Those who are in partial remission receive low dose (30Gy) involved node radiotherapy. Stable or progressive disease at any moment is assumed as a trial failure and new therapeutic strategies are offered to patients off protocol. Chemotherapy is based upon regimes with well known effectiveness in Hodgkin lymphoma. (i.e. ABVD: doxorubicin, bleomycin, vinblastine and dacarbazine and ESHAP: Etoposide, methyl prednisolone, citarabine and cisplatin). The schedules are delivered with low cumulative drug doses and avoiding the use of toxic alkylating agents. Risks of secondary leukemia and infertility are thus minimized. Doxorubicin and bleomycin do not achieve cumulative doses that may expose to significant risk of heart or lung damage. Radiotherapy reduction avoids late radiation sequels. This clinical study proposes a therapeutic approach based on chemotherapy that do not sum up high cumulative toxic doses. Therapy is tailored according to initial risk assessment and disease responsiveness. Those who achieve a complete response to chemotherapy do not receive additional radiotherapy, thus avoiding further late effects.

Key facts

Study ID

NCT03500133

Run by

Hospital JP Garrahan

People needed

500

Starts

2017-10-06

Expected to finish

2032-10-31

Last updated by the study team

2025-04-16

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histopathological diagnosis of classical Hodgkin lymphoma.
• Normal renal, hepatic, pulmonary and metabolic function standards.
• Informed consent signed by patient and/or legal caretakers.

You may not qualify if…

• 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 it is running

• Hospital JP Garrahan — Buenos Aires, Buenos Aires F.D., Argentina (enrolling)

Full record on ClinicalTrials.gov

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