Pediatric Hodgkin Lymphoma Treatment Trial With Low Cumulative Doses of Chemotherapy Agents and Reduced Radiation.
Status:
Recruiting
Trial end date:
2032-10-31
Target enrollment:
Participant gender:
Summary
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.