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Phase II study of interim FDG-PET-guided response-adapted therapy in pediatric patients with Hodgkin's lymphoma (HL-14)

Phase II study of interim FDG-PET-guided response-adapted therapy in pediatric patients with Hodgkin's lymphoma (HL-14) - Phase II study of interim FDG-PET-guided response-adapted therapy in pediatric patients with Hodgkin's lymphoma (HL-14)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019093
Enrollment
50
Registered
2015-10-01
Start date
2015-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin&#39

Interventions

Omit radiation therapy for FDG-PET negative cases after 2 courses of multi-drug chemotherapy

Sponsors

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) diagnosis of Hodgkin's lymphoma (2) age under 20 year old at diagnosis (3) registration at JPLSG CHM-14 study (4) written informed consent obtained from patient or guardians.

Exclusion criteria

Exclusion criteria: (1) Cases where impaired liver, kidney and cardiac functions compromise experimental treatment (2) Patients who have been treated with anticancer drugs or radiation therapy (3) Presence of CNS degenerative lesion (4) Associated intracranial hemorrhage which hinders execution of treatment process (5) Associated infection which is difficult to control (6) Pregnant or possibility of pregnancy (7) Women who are breastfeeding (8) Past history of malignant neoplasm or multiple primary neoplasms (9) History of congenital or acquired immune deficiency syndrome (10) Any other reasons that the attending physician has deemed unsuitable

Design outcomes

Primary

MeasureTime frame
5-year event-free survival

Secondary

MeasureTime frame
5-year overall survival ratio of complete remission ratio of interim-PET negative ratio of acute and late side effect

Countries

Japan

Contacts

Public ContactYuhki Koga

Graduate School of Medical Sciences Kyushu University Department of Pediatrics

yuuki-k@pediatr.med.kyushu-u.ac.jp092-642-5093

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026