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

Sponsor
Children's Cancer Group, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT04726501
Collaborator
Shanghai Children's Medical Center (Other)
200
Enrollment
3
Locations
3
Arms
117
Anticipated Duration (Months)
66.7
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Combined chemotherapy with or without involved-field radiotherapy
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Secondary Outcome Measures

  1. Overall survival (OS) [5 year OS]

    OS was measured from the day of diagnosis to the date of death.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 18 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1West China Second University Hospital, Sichuan University, Chengdu, ChinaChengduChina
2Nanjing Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu, ChinaNanjingChina
3Shanghai Children's Medical CenterShanghaiChina200127

Sponsors and Collaborators

  • Children's Cancer Group, China
  • Shanghai Children's Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Children's Cancer Group, China
ClinicalTrials.gov Identifier:
NCT04726501
Other Study ID Numbers:
  • CCCG-HD-2018
First Posted:
Jan 27, 2021
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2022