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EuroNet-PHL-LP1: complete resection or low-dose chemotherapy for pediatric low-risk nodular lymphocyte-predominant
Ananth G Shankar1, Judith Landman-Parker2, Maurizio Mascarin3
1Children and Young People's Cancer Services, University College London Hospitals NHS Foundation Trust, London, United Kingdom.
Abstract:
Children and adolescents with early-stage nodular lymphocyte-predominant Hodgkin lymphoma (nLPHL) have a 5-year event-free survival (EFS) of ∼77% after complete lymph node resection and ∼89% with anthracycline-containing chemotherapy. We investigated whether those patients can be successfully treated with surgical resection alone or with low-intensity, anthracycline-free CVP (cyclophosphamide, vinblastine, and prednisone) chemotherapy. EuroNet-PHL-LP1 was a prospective phase 3 trial enrolling patients aged <18 years with stage IA/IIA nLPHL. Complete resection led to active surveillance. Patients with unresectable disease received 3 cycles CVP. In CVP cohort 1, treatment cessation required negative 2-deoxy-2-[fluorine-18]fluoro-d-glucose positron emission tomography (18F-FDG PET). An amendment in 2014 omitted PET for end-of-treatment response; computed tomography and/or magnetic resonance imaging alone defined response in CVP cohort 2. The primary endpoint was 5-year EFS, with death, relapse, second malignancy, and PET positivity counting as events; for CVP cohort 2, progression-free survival (PFS) was primary. Among 267 registered patients, 247 were evaluable. Seventy-eight underwent resection only; their 5-year EFS/PFS was 79.5%. Six of 18 patients who relapsed after surgical resection reentered the CVP arm. In CVP cohort 1, 51 of 82 (62%) achieved complete metabolic response (CMR). Five-year EFS was 56.4%, whereas 5-year PFS in the CMR group was 91.3%. In contrast, PFS in 84 patients in CVP cohort 2 was 64.7%. During CVP, 68.3% of patients experienced grade 3 to 4 neutropenia. No treatment-related deaths were reported. Excellent outcomes were achieved after complete resection and with low-intensity, anthracycline-free chemotherapy if in CMR after chemotherapy. This strategy now constitutes the EuroNet-PHL standard of care for early-stage nLPHL. The trial was registered at www.clinicaltrialsregister.eu as EudraCT 2007-004092-19.
