CCCG-HD-2018 for Children and Adolescents With Newly Diagnosed Hodgkin Lymphoma
A Prospective Multi-center Study for the Treatment of Chinese Children and Adolescents With Newly Diagnosed Hodgkin Lymphoma Using a Modified COG Strategy
1 other identifier
interventional
200
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2018
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 23, 2021
CompletedFirst Posted
Study publicly available on registry
January 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedMarch 19, 2026
March 1, 2026
7.8 years
January 23, 2021
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Event free survival (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.
5 year EFS
Secondary Outcomes (1)
Overall survival (OS)
5 year OS
Study Arms (3)
Low risk group
EXPERIMENTALAnn Arbor stage IA or IIA without bulky disease.
Intermediate risk group
EXPERIMENTALAnn Arbor stages IB, IAE, IIB, IIAE, IIIA, IVA with or without bulk disease, and IA or IIA with bulk disease
High risk group
EXPERIMENTALAnn Arbor stages III or IV with B symptoms
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Cancer Group, Chinalead
- Shanghai Children's Medical Centercollaborator
Study Sites (3)
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, 200127, China
Related Publications (4)
Keller FG, Castellino SM, Chen L, Pei Q, Voss SD, McCarten KM, Senn SL, Buxton AB, Bush R, Constine LS, Schwartz CL. Results of the AHOD0431 trial of response adapted therapy and a salvage strategy for limited stage, classical Hodgkin lymphoma: A report from the Children's Oncology Group. Cancer. 2018 Aug 1;124(15):3210-3219. doi: 10.1002/cncr.31519. Epub 2018 May 8.
PMID: 29738613BACKGROUNDKahn JM, Kelly KM, Pei Q, Bush R, Friedman DL, Keller FG, Bhatia S, Henderson TO, Schwartz CL, Castellino SM. Survival by Race and Ethnicity in Pediatric and Adolescent Patients With Hodgkin Lymphoma: A Children's Oncology Group Study. J Clin Oncol. 2019 Nov 10;37(32):3009-3017. doi: 10.1200/JCO.19.00812. Epub 2019 Sep 20.
PMID: 31539308RESULTFriedman DL, Chen L, Wolden S, Buxton A, McCarten K, FitzGerald TJ, Kessel S, De Alarcon PA, Chen AR, Kobrinsky N, Ehrlich P, Hutchison RE, Constine LS, Schwartz CL. Dose-intensive response-based chemotherapy and radiation therapy for children and adolescents with newly diagnosed intermediate-risk hodgkin lymphoma: a report from the Children's Oncology Group Study AHOD0031. J Clin Oncol. 2014 Nov 10;32(32):3651-8. doi: 10.1200/JCO.2013.52.5410. Epub 2014 Oct 13.
PMID: 25311218RESULTGao YJ, Tang JY, Pan C, Lu FJ, Xue HL, Chen J. Risk-adapted chemotherapy without procarbazine in treatment of children with Hodgkin lymphoma. World J Pediatr. 2013 Feb;9(1):32-5. doi: 10.1007/s12519-012-0390-0. Epub 2012 Dec 29.
PMID: 23275102RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2021
First Posted
January 27, 2021
Study Start
April 1, 2018
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- The data were transferred every 12 months during the study period.
- Access Criteria
- All the data is sharing through paper work every 12 months and meeting discussion every year.
Each centre was responsible for its own data collection. A predefined set of data was collected on protocol-specific forms for each patient and sent to a coordinating center where the findings were reviewed for consistency and completeness. The data were transferred every 12 months. All 12-month reports were reviewed by each local investigator.