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Active, not recruiting Phase 4

CCCG-HD-2018 for Children and Adolescents With Newly Diagnosed Hodgkin Lymphoma

NCT04726501 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2018-04-01
Last updated
2026-03-19

Condition(s) studied

Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

Combined chemotherapy with or without involved-field radiotherapy

Combined chemotherapy with or without involved-field radiotherapy: Patients in low risk group receive 4 cycles of AVE-PC with or without involved-field radiotherapy (IFRT). Patients in intermediate risk group4 cycles ABVE-PC with or without IFRT. RERs in high risk group receive 4 cycles of ABVE-PC followed by followed by IFRT. SERs in high risk group receive 2 cycles of ABVE-PC followed by 2 cycles of IFOS/VINO and 2 cycles of ABVE-PC then followed by IFRT. IFRT consists of 21 Gy in 14 fractions of 1.5 Gy per day and is scheduled within 4 weeks after chemotherapy.

Study summary

The incidence of Hodgkin's lymphoma (HL) in Chinese children and adolescents is only 1 / 10 of that in Europe and the United States, which is a "rare" childhood tumor. Due to the "drug shortage" and extremely low incidence, it has brought great difficulties to the domestic clinical research and failed to achieve the desired effect. In this study, we apply a well-documented effective protocol on newly diagnosed children and adolescents with HL to understand whether the same treatment regimens can obtain similar event free survival rates and overall survival rates and then find out the problems existing in the current clinical care of HL in China, so as to make continuous improvement in the future and prepare for innovative clinical research.

Eligibility

Sex
ALL
Min age
1 Year
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Patient must be ages 1 to 18 years at the time of diagnosis; Newly diagnosed, histologically confirmed Hodgkin disease (No nodular lymphocyte-predominant Hodgkin lymphoma) Exclusion Criteria: * Patients have received prior cytotoxic chemotherapy for the current diagnosis or any cancer, if any steroid applied, total prior steroids dosage \< Prednisone 80 mg/m2; Patients have congenital immunodeficiency, HIV infection, or prior organ transplant; Patients have overwhelming infection, and a life expectancy of \< 2 weeks

Primary outcome measure(s)

  • Event free survival (EFS) — 5 year EFS
    EFS was measured from the day of diagnosis to an event (relapse or progression, death for any reason, abandonment of treatment, second malignancy) or to the date of the last follow-up contact.

Trial sites (3)

FacilityCityRegionStatus
West China Second University Hospital, Sichuan University, Chengdu, China Chengdu China
Nanjing Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu, China Nanjing China
Shanghai Children's Medical Center Shanghai China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04726501 on ClinicalTrials.gov ↗ ← All trials in China