Thereapeutic Recommendantion for Children With a Hodgkin... | NCT05407480

Studies
Thereapeutic Recommendantion for Children With a Hodgkin Lymphoma

NCT05407480

Sponsor

French Africa Pediatric Oncology Group

Status

Recruiting

Last Update Posted

Mar 2, 2026Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Staging
Therapeutic Recommendations

Interventions

Observational

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2022Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Jun 2, 2022

First Submission Date that Met QC Criteria

Jun 2, 2022

First Posted Date

Jun 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2026

Last Update Posted Date

Mar 2, 2026Actual

Name	Class
Gustave Roussy, Cancer Campus, Grand Paris	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Descriptive data will be collected to evaluation compliance with the protocol and to evaluate outcome

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brenda MS MALLON	Contact	0033 142115411		brenda.mallon@gustaveroussy.fr
FATEN Ben Ayed, Professeur	Contact			faten.fedhila@yahoo.fr

Overall Officials

Name	Affiliation	Role
FATEN Ben Ayed, Professeur	French Africa Pediatric Oncology Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brenda Mallon	Recruiting	Paris	France	94805	France

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided