Clinical trials for the treatment of acute myeloid leukemia in children and adolescents

Phase 1

• Conditions: AML; MedDRA version: 18.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-000018-39-DE
• Lead Sponsor: Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH gGmbH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-09
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 625

Inclusion Criteria

• diagnosis of AML (according to WHO classification 2008)
• Acute leukemia with mixed line assignment and myeloid dominance (MPAL; according to WHO classification 2008: included dominant myeloid biphenotypic leukemia, and acute undifferentiated leukemia (AUL))
• Age 0 to 18 years old
• Consent for study participation and for data processing and data dissemination
Are the trial subjects under 18? yes
Number of subjects for this age range: 625
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

• Patients with acute promyelocytic leukemia / AML with t (15, 17); PML / RARA
• pre-existing conditions / syndromes which preclude treatment
• Patients with trisomy 21 and ML-DS and / or transient myeloproliferative syndrome (reference to the TMD-prevention study or the ML-DS 2006 Study)
• Acute leukemias bilineäre
• Secondary acute myeloid leukemia observation patients
• refusal of treatment
• Participation in another clinical trial, the Invention could affect the questions of this study
• Pregnancy
• Lactation
• Hypersensitivity to clofarabine
• patients of reproductive age who reject an effective pregnancy prevention
• previous treatment with cytostatic drugs for more than 14 days

Study & Design

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