GFAOPLH2019: Thereapeutic Recommendantion for Children With a Hodgkin Lymphoma

Sponsor
French Africa Pediatric Oncology Group (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05407480
Collaborator
Gustave Roussy, Cancer Campus, Grand Paris (Other)
250
1
63.6
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational

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 Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Therapeutic Recommendations for Children Registered in the RFAOP Register and With a Hodgkin Lymphoma
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2027
Anticipated Study Completion Date :
Nov 20, 2027

Outcome Measures

Primary Outcome Measures

  1. Patient status [24 months]

    Dead or Alive

  2. Drugs [24 months]

    The evaluation of the number of children who remain untreated because of lack of acess to chemotherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Months to 18 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brenda Mallon Paris France 94805

Sponsors and Collaborators

  • French Africa Pediatric Oncology Group
  • Gustave Roussy, Cancer Campus, Grand Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
French Africa Pediatric Oncology Group
ClinicalTrials.gov Identifier:
NCT05407480
Other Study ID Numbers:
  • GFAOP LH 2019
First Posted:
Jun 7, 2022
Last Update Posted:
Jul 21, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022