CCCG-HD-2018 for Children and Adolescents With Newly Diagnosed Hodgkin Lymphoma
Primary Purpose
Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Combined chemotherapy with or without involved-field radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma
Eligibility Criteria
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
Sites / Locations
- West China Second University Hospital, Sichuan University, Chengdu, ChinaRecruiting
- Nanjing Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu, ChinaRecruiting
- Shanghai Children's Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low risk group
Intermediate risk group
High risk group
Arm Description
Ann Arbor stage IA or IIA without bulky disease.
Ann Arbor stages IB, IAE, IIB, IIAE, IIIA, IVA with or without bulk disease, and IA or IIA with bulk disease
Ann Arbor stages III or IV with B symptoms
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall survival (OS)
OS was measured from the day of diagnosis to the date of death.
Full Information
NCT ID
NCT04726501
First Posted
January 23, 2021
Last Updated
September 1, 2023
Sponsor
Children's Cancer Group, China
Collaborators
Shanghai Children's Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04726501
Brief Title
CCCG-HD-2018 for Children and Adolescents With Newly Diagnosed Hodgkin Lymphoma
Official Title
A Prospective Multi-center Study for the Treatment of Chinese Children and Adolescents With Newly Diagnosed Hodgkin Lymphoma Using a Modified COG Strategy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Cancer Group, China
Collaborators
Shanghai Children's Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
In this study, enrolled patients from age 1 through 18 years with newly diagnosed and biopsy-proven HL are stratified into 3 risk groups according to 3 COG published trials: AHOD0831 (high risk-all Ann Arbor stages III and IV with B symptoms), AHOD0031 (intermediate risk-Ann Arbor stages IB, IAE, IIB, IIAE, IIIA, IVA with or without bulk disease, and IA or IIA with bulk disease) and AHOD0431 (low risk-Ann Arbor stage IA or IIA without bulky disease). Staging was determined with contrast-enhanced CT scanning or MRI, bilateral bone marrow biopsies and FDG-PET. B symptoms included weight loss > 10%, unexplained recurrent fever > 38°, or drenching night sweats. Bulk disease included a mediastinal mass with diameter greater than one third of the thoracic diameter on an upright anterior-posterior (AP) chest radiograph or extramediastinal nodal aggregate > 6 cm in the longest transverse diameter on axial CT.
Low risk group: Patients receive 2 cycles of doxorubicin,vincristine, etoposide, cyclophosphamide, and prednisone (AVE-PC) followed by early response (ER) evaluation. Rapid early responders (RERs) receive 2 additional AVE-PC cycles. Slow early responders (SERs) receive 2 additional ABVE-PC cycles followed by involved-field radiotherapy (IFRT). IFRT consists of 21 Gy in 14 fractions of 1.5 Gy per day and is scheduled within 4 weeks after chemotherapy.
Intermediate risk group: Patients receive 2 cycles of doxorubicin, bleomycin, vincristine, etoposide, cyclophosphamide, and prednisone (ABVE-PC) followed by ER evaluation. RERs receive 2 additional ABVE-PC cycles. SERs receive 2 additional ABVE-PC cycles 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.
High risk group: Patients receive 2 cycles of ABVE-PC followed by ER evaluation. RERs receive 2 additional ABVE-PC cycles followed by IFRT. SERs receive 2 cycles of IFOS/VINO and 2 cycles of ABVE-PC 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.
Patients who have disease progression at any time will be removed from this protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low risk group
Arm Type
Experimental
Arm Description
Ann Arbor stage IA or IIA without bulky disease.
Arm Title
Intermediate risk group
Arm Type
Experimental
Arm Description
Ann Arbor stages IB, IAE, IIB, IIAE, IIIA, IVA with or without bulk disease, and IA or IIA with bulk disease
Arm Title
High risk group
Arm Type
Experimental
Arm Description
Ann Arbor stages III or IV with B symptoms
Intervention Type
Other
Intervention Name(s)
Combined chemotherapy with or without involved-field radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Event free survival (EFS)
Description
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.
Time Frame
5 year EFS
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS was measured from the day of diagnosis to the date of death.
Time Frame
5 year OS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Jin Gao
Phone
0086-21-38626161
Ext
82064
Email
gaoyijin@scmc.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Li Han
Phone
0086-21-38626161
Ext
82065
Email
hanyali@scmc.com.cn
Facility Information:
Facility Name
West China Second University Hospital, Sichuan University, Chengdu, China
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Guo
Email
guoxkl@163.com
First Name & Middle Initial & Last Name & Degree
Ju Gao
Email
gaoju651220@126.com
First Name & Middle Initial & Last Name & Degree
Ju Gao
Facility Name
Nanjing Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Wang
Email
wangjun_1008@189.cn
First Name & Middle Initial & Last Name & Degree
Yong-Jun Fang
Email
fyj322@189.cn
Facility Name
Shanghai Children's Medical Center
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Jin Gao, M.D.
Phone
86-21-38626161
Ext
82064
Email
gaoyijin@scmc.com.cn
First Name & Middle Initial & Last Name & Degree
Jing-yan Gao, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data were transferred every 12 months during the study period.
IPD Sharing Access Criteria
All the data is sharing through paper work every 12 months and meeting discussion every year.
Citations:
PubMed Identifier
29738613
Citation
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.
Results Reference
background
PubMed Identifier
31539308
Citation
Kahn 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.
Results Reference
result
PubMed Identifier
25311218
Citation
Friedman 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.
Results Reference
result
PubMed Identifier
23275102
Citation
Gao 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.
Results Reference
result
Learn more about this trial
CCCG-HD-2018 for Children and Adolescents With Newly Diagnosed Hodgkin Lymphoma
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