EUCTR2018-002988-25-NLActive, not recruitingPhase 1
Phase III Clinical Trial for CPX-351 in Myeloid Leukemia in Children with Down Syndrome 2018
Gesellschaft für Pädiatrische Onkologie & Hämatologie (GPOH gGmbH)0 sites150 target enrollmentStarted: April 1, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Myeloid Leukemia (ML) or Myelodysplastic Syndrome (MDS), according to WHO
- •Trisomy 21: Down syndrome or mosaic
- •Age: > 6 months and = 4 years of age with/without GATA1 mutation OR > 4 years of age < 6 years of age with GATA1 mutation
- •Morphology/Immunophenotyping: FAB M0, M6 or M7
- •Lansky performance score at least equal to 50; or Karnofsky performance status at least equal to 50, whichever is applicable
- •Understand and voluntarily provide written permission of parental/legal representative(s) to the ICF prior to conducting any study related assessments/procedures, also concerning data and tumor material transfer according to ICH/GCP and national/local regulations
- •Able to adhere to the study visit schedule and other protocol requirements
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •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
- •Children with Transient Abnormal Myelopoiesis (TAM), according to WHO
- •Cytogenetics: AML with recurrent genetic abnormalities (WHO 2016)
- •Previous allogeneic bone marrow, stem cell or organ transplantation
- •Evidence of invasive fungal infection or other severe systemic infection requiring treatment doses of systemic/parenteral therapy including known active viral infection with human immunodeficiency virus (HIV) or Hepatitis Type B and C
- •Symptomatic cardiac disorders (CTCAE 4.0 Grade 3 or 4)
- •Major surgery within 21 days of the first dose.
- •Any anti-cancer therapy (e.g., intensive chemotherapy, biologics or radiotherapy) for more than 14 days or within 4 weeks before start of therapy, except low-dose cytarabine for the treatment of TAM.
- •Concomitant treatment with any other anticancer therapy except those specified in protocol during the study therapy
- •Treated by any investigational agent in a clinical study within previous 4 weeks
- •History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- •Former Enrolment to this study
Investigators
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