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Clinical Trials/NCT05407480
NCT05407480RecruitingNot Applicable

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

French Africa Pediatric Oncology Group2 sites in 1 country250 target enrollmentStarted: November 15, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
250
Locations
2
Primary Endpoint
Patient status

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
0 Months to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Patient status

Time Frame: 24 months

Dead or Alive

Drugs

Time Frame: 24 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
French Africa Pediatric Oncology Group
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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