Thereapeutic Recommendantion for Children With a Hodgkin Lymphoma

Staging Clinical Trial

— GFAOPLH2019  

Official title:

Therapeutic Recommendations for Children Registered in the RFAOP Register and With a Hodgkin Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05407480
• Other study ID #: GFAOP LH 2019
• Status: Recruiting
• Start date: November 15, 2022
• Est. completion date: November 20, 2034

Study information

• Verified date: March 2023
• Source: French Africa Pediatric Oncology Group
• Contact: Brenda MS MALLON
• Phone: 0033 142115411
• Email: brenda.mallon[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The GFAOP propose a simple and reproducible staging according to clinical, biological and radiological data.

Develop standardized but different therapeutic recommendations based on the availability or lack of radiation therapy in the pilot unites who will adapt these recommendations.

Description:

In high-income countries, therapeutic outcomes exceed 90% and therapeutic de-escalation is necessary to reduce mainly the effects of long-term radiotherapy. Within the same country, there are also differences between the therapeutic protocols used in the different centres.

The Experience of Sub-Saharan African Units of the Franco-African Paediatric Oncology Group (GFAOP) in the treatment of pediatric Hodgkin lymphoma in 104 patients was based on chemotherapy alone. The latter was based on COPP/ABV cures without complementary irradiation adapted to the initial stratification and modulated according to the morphological response. Overall survival at 5 years was 82% at 30 months after a median decrease of 17 months.

It seemed appropriate to bring together in a single committee the representatives of the various pilot units in order to standardize the therapeutic protocols in the African countries.

So with this recommendation the GFAOP propose a simple and reproducible staging according to clinical, biological and radiological data.

• Develop standardized but different therapeutic recommendations based on the availability or lack of radiation therapy in the pilot unit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 20, 2034
• Est. primary completion date: August 1, 2029
• Gender: All
• Age group: 0 Months to 18 Years

Eligibility

Inclusion Criteria:

under 18 years of age at diagnosis

• suffering from "classical" Hodgkin's disease according to the WHO classification.

• with no history of hematological malignancies or constitutional or acquired immune deficiencies

Exclusion Criteria:

• Over 18 years of age at diagnosis

• A history of hematological malignancies or a history of constitutional or a history of acquired immune deficiencies

Related Conditions & MeSH terms

• Hodgkin Disease
• Staging

Intervention

Other:
• Observational
Descriptive data will be collected to evaluation compliance with the protocol and to evaluate outcome

Locations

Country	Name	City	State
France	Brenda Mallon	Paris

Sponsors (2)

Lead Sponsor	Collaborator
French Africa Pediatric Oncology Group	Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient status	Dead or Alive	24 months
Primary	Drugs	The evaluation of the number of children who remain untreated because of lack of acess to chemotherapy	24 months