Pediatric Hodgkin Lymphoma Treatment Trial With Low Cumulative Doses of Chemotherapy Agents and Reduced Radiation.

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2024
• Main ID: NCT03500133
• Date of registration: 09/04/2018
• Prospective Registration: No
• Primary sponsor: Hospital JP Garrahan
• Public title: Pediatric Hodgkin Lymphoma Treatment Trial With Low Cumulative Doses of Chemotherapy Agents and Reduced Radiation. LHGALOP2017
• Scientific title: Non Randomized, Multicenter, Prospective Pediatric Hodgkin Lymphoma Treatment Trial Stratified According to Initial Risk Factors and Response to Chemotherapy, Reduced Cumulative Doses of Antineoplastic Agents and Radiotherapy.
• Date of first enrolment: October 6, 2017
• Target sample size: 500
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03500133
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Argentina

Contacts

• Name: Silvina Ruvinsky, MD

• Name: Pedro A Zubizarreta, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histopathological diagnosis of classical Hodgkin lymphoma.

- Normal renal, hepatic, pulmonary and metabolic function standards.

- Informed consent signed by patient and/or legal caretakers.

Exclusion Criteria:

- Lymphocyte predominant nodular Hodgkin lymphoma

- Any form of immunodeficiency before diagnosis. (primary immunodeficiencies, trasplant
recipients or immunosuppressive therapies of any kind including corticoid therapies
during 28 days before diagnosis).

- Pregnancy and breastfeeding period.

- Sexually active female patients who do not accept an effective contraceptive method
during therapy.

- Positive HIV serology.

- Penfigus or hepatic ductopenia.

- Hodgkin lymphoma as a secondary malignant disease.



Age minimum: 2 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pediatric Hodgkin's Disease

Intervention(s)

Drug: Intermediate risk with complete early response after two cycles of ABVD chemotherapy schedule. Three more ABVD courses are delivered.

Drug: Intermediate risk with partial remission after two cycles of ABVD chemotherapy schedule. Four more chemotherapy courses are delivered alternating ESHAP and ABVD.

Radiation: No radiotherapy if CR at the end of chemotherapy.

Drug: Low risk with complete early response after two cycles of ABVD chemotherapy schedule. Only one more ABVD course is delivered.

Drug: Low risk with partial remission at early response assessment after two cycles of ABVD chemotherpay schedule. Two ABVD courses are delivered.

Drug: High risk with partial remission after 1 ABVD and 1 ESHAP courses. Six more chemotherapy courses are delivered alternating ESHAP and ABVD.

Drug: High risk with complete early response after 1 ABVD and 1 ESHAP courses. Four more chemotherapy courses are delivered alternating ESHAP and ABVD.

Drug: Low risk with partial remisssion after 4 cycles of ABVD chemotherapy schedule. Two ESHAP courses are delivered.

Radiation: IN 30Gy RT in case of PR at the end of chemotherapy

Primary Outcome(s)

Event-free Survival [Time Frame: 3-10 years]

Overall Survival [Time Frame: 3-10 years]

Secondary Outcome(s)

Acute, chronic or late toxic events [Time Frame: 0-10 years]

Secondary ID(s)

991 Hodgkin Lymphoma GALOP2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital Pereyra Rosell, Montevideo, Uruguay