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

Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726501
• Other study ID #: CCCG-HD-2018
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2023
• Source: Children's Cancer Group, China
• Contact: Yi-Jin Gao
• Phone: 0086-21-38626161
• Email: gaoyijin[@]scmc.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
Children's Cancer Group, China	Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

References & Publications (4)

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 adolesc — View 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. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	OS was measured from the day of diagnosis to the date of death.	5 year OS