Thereapeutic Recommendantion for Children With a Hodgkin Lymphoma

Recruiting

• Conditions: Staging; Therapeutic Recommendations

• Registration Number: NCT05407480
• Lead Sponsor: French Africa Pediatric Oncology Group

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-07
• Study Start: 2022-11-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2029-08-01
• Study Completion: 2034-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient status	24 months	Dead or Alive
Drugs	24 months	The evaluation of the number of children who remain untreated because of lack of acess to chemotherapy

Trial Locations

Locations (1)

Brenda Mallon; 🇫🇷 Paris, France