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

September 1, 2023 updated by: Children's Cancer Group, China

A Prospective Multi-center Study for the Treatment of Chinese Children and Adolescents With Newly Diagnosed Hodgkin Lymphoma Using a Modified COG Strategy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Chengdu, China
        • Recruiting
        • West China Second University Hospital, Sichuan University, Chengdu, China
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ju Gao
      • Nanjing, China
        • Recruiting
        • Nanjing Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
        • Contact:
        • Contact:
      • Shanghai, China, 200127
        • Recruiting
        • Shanghai Children's Medical Center
        • Contact:
        • Contact:
          • Jing-yan Gao, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low risk group
Ann Arbor stage IA or IIA without bulky disease.
Other: 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.
Experimental: Intermediate risk group
Ann Arbor stages IB, IAE, IIB, IIAE, IIIA, IVA with or without bulk disease, and IA or IIA with bulk disease
Other: 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.
Experimental: High risk group
Ann Arbor stages III or IV with B symptoms
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event free survival (EFS)
Time Frame: 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.
5 year EFS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 5 year OS
OS was measured from the day of diagnosis to the date of death.
5 year OS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer Group, China

Collaborators

Shanghai Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 23, 2021

First Submitted That Met QC Criteria

January 23, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCCG-HD-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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