Risk Adapted Therapy of Hodgkin Lymphoma in Upper Egypt

Pediatric Hodgkin Lymphoma Clinical Trial

Official title:

Risk Adapted Therapy of Hodgkin Lymphoma in Upper Egypt

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06340243
• Other study ID #: HODGKIN
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

determine if radiotherapy could be safely omitted for early hodgkin lymphoma responder patients without compromising outcome

Description:

Hodgkin's lymphoma accounts for around 40% of all pediatric lymphomas and is the most prevalent cancer among adolescents and young adults. With combinations of chemotherapy and radiation, Hodgkin's lymphoma is roughly 80% curable, placing it among the most treatable cancers . Since the introduction of combination chemotherapy treatments 20 years ago, the prognosis for children with Hodgkin's lymphoma has improved. The treatment is mostly influenced by the stage of the disease at diagnosis, histology, existence of "B"-symptoms, and the presence of bulky disease. Nonetheless, 20% of patients do not achieve long-term remission, and around 20% experience treatment-related side effects such as secondary malignancies, infertility, cardiovascular disease, and organ malfunction following chemo-radiation .Studies of long-term therapy side effects were made possible by the significant number of survivors. The goal of therapy optimization protocols for pediatric patients with Hodgkin's lymphoma is to maintain excellent tumor control while limiting adverse effects and long-term consequences . It is critical to stratify patients based on reliable prognostic factors at presentation and according to the rapidity of response into low-risk (LR) patients who would benefit from less aggressive therapy, avoiding unnecessary toxic side effects, and high-risk (HR) patients who should be subjected to intensified therapy to reduce the rate of treatment failures and relapses .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• Previously untreated patients younger than 18 years old with classical Hodgkin lymphoma

Exclusion Criteria:

• Patients aged more than 18 years old.

• Patients who died early at presentation before starting chemotherapy

• diagnosis of nodular lymphocytic predominant Hodgkin lymphoma

• previous chemotherapy or radiotherapy other (simultaneous) malignancies

• severe concomitant diseases (eg, immune deficiency syndrome); or known HIV positive.

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Pediatric Hodgkin Lymphoma

Intervention

Radiation:
• radiotherapy
radiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the outcome of pediatric patients with HL treated with risk- and response-adjusted therapy	determine if radiotherapy could be safely omitted for early responder patients without compromising outcome, it can be assessed by decrease in lymph node volume ,Volumes are approximated as ellipsoids. If a, b, c denote the principal axes of the ellipsoid the volume is calculated as V= (a x b x c)/2	2 years