Thereapeutic Recommendantion for Children With a Hodgkin Lymphoma (GFAOPLH2019)

March 16, 2023 updated by: French Africa Pediatric Oncology Group

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

250

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

  • France
      • Paris, France, 94805
        • Recruiting
        • Brenda Mallon
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Fatou-Binetou DIAGNE AKONDE, DR
        • Sub-Investigator:
          • Chantal BOUDA, DR
        • Sub-Investigator:
          • Mbola RAKOTOMAHEFA, PROF
        • Sub-Investigator:
          • Aléine BUDIONGO, DR

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 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children arriving in one of the participating units :

under 18 years of age at diagnosis and suffering from "classical" Hodgkin's disease according to the WHO classification.

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient status
Time Frame: 24 months
Dead or Alive
24 months
Drugs
Time Frame: 24 months
The evaluation of the number of children who remain untreated because of lack of acess to chemotherapy
24 months

Collaborators and Investigators

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

Sponsor

French Africa Pediatric Oncology Group

Collaborators

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Principal Investigator: FATEN Ben Ayed, Professeur, French Africa Pediatric Oncology Group

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)

November 15, 2022

Primary Completion (Anticipated)

August 1, 2029

Study Completion (Anticipated)

November 20, 2034

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFAOP LH 2019

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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