Clinical trial • Phase III • Oncology

Levothyroxine for Hodgkin lymphoma | Non-Hodgkin lymphoma | Medulloblastoma

Phase III trial of Levothyroxine for Hodgkin lymphoma | Non-Hodgkin lymphoma | Medulloblastoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Hodgkin lymphoma | Non-Hodgkin lymphoma | Medulloblastoma
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
08-03-2024
First CTIS Authorization Date
24-05-2024

Trial design

Randomised, radiotherapy alone versus radiotherapy + levo-thyroxin (levothyroxine). dose and schedule of levothyroxine in the trial are not specified in the record.-controlled Phase III trial across 1 site in Italy.

Randomised
Yes
Comparator
Radiotherapy alone versus Radiotherapy + Levo-thyroxin (Levothyroxine). Dose and schedule of levothyroxine in the trial are not specified in the record.
Target Sample Size
65
Trial Duration For Participant
1095

Eligibility

Recruits 65 paediatric patients.

Vulnerable Population
Includes pediatric patients. Written informed consent required prior to any study-specific analysis and/or data collection. No specific assent procedures or guardian consent details are provided in the record.

Inclusion criteria

  • {"criterion_text":"- Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma BEFORE RADIOTHERAPY (RT) PLANNING INCLUDING THYROID PARENCHYMA without previous primary or secondary hypothyroidism;\n- Written informed consent prior to any study-specific analysis and/or data collection."}

Exclusion criteria

  • {"criterion_text":"- Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma after radiotherapy including thyroid parenchyma;\n- Not signed consent."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Hypothyroidism-free survival at 3 years after radiotherapy including part or the whole thyroid parenchima on the intention-to-treat population will be the main end-point. For both treatment groups (radiotherapy / radiotherapy + Levo-thyroxin), the analysis set will consist of patients evaluated with TSH blood dosage to evaluate the onset of hypothyroidism within three years from the radiotherapy beginning.","definition_or_measurement_approach":"Measured as hypothyroidism-free survival at 3 years on the intention-to-treat population; onset of hypothyroidism evaluated by TSH blood dosage within three years from radiotherapy start."}

Recruitment

Planned Sample Size
65
Recruitment Window Months
96
Consent Approach
Written informed consent prior to any study-specific analysis and/or data collection. No details provided on age-specific consent/assent documents or languages; no specific assent or parental consent procedure described in the record.

Geography

Total Number Of Sites
1
Total Number Of Participants
65

Italy

Earliest CTIS Part Ii Submission Date
08-03-2024
Latest Decision Or Authorization Date
24-05-2024
Processing Time Days
77
Number Of Sites
1
Number Of Participants
65

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Pediatric Oncology
Principal Investigator Name
Maura Massimino
Principal Investigator Email
maura.massimino@istitutotumori.mi.it
Contact Person Name
Maura Massimino

Sponsor

Primary sponsor

Full Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
Levotiroxina Teva 25 microgrammi compresse
Active Substance
Levothyroxine
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Marketing authorisation present (authorisationCountryCode: IT, marketingAuthNumber: 040619049)
Maximum Dose
2 µg/Kg (maxDailyDoseAmount: 2; doseUom: µg/Kg)
Combination Treatment
Yes

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