DexaDays-2 study

Phase 1

• Conditions: Acute lymphoblastic leukemia; MedDRA version: 20.0Level: LLTClassification code 10024338Term: Leukemia lymphoblastic acuteSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002738-22-NL
• Lead Sponsor: Princess Máxima Center of Pediatric Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-09
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

- Written informed consent
- Age 3-18
- Histologically or cytologically confirmed acute lymphoblastic leukemia (ALL)
- Inclusion in DCOG ALL medium risk group protocol
- Able to comply with scheduled follow-up
Are the trial subjects under 18? yes
Number of subjects for this age range: 105
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patient or parent refusal
- Anticipated compliance problems
- Underlying conditions which affect the absorption of oral medication
- Pregnant or lactating patients
- Current uncontrolled infection or any other complication which may interfere with
dexamethasone treatment
- Language barrier
- Pre-existing mental retardation
- Current oral hydrocortisone use
- Risperidone use

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified