Treatment of children and adolescents with a diagnosis of chronic myeloid leukemia by transplantation of stem cells from a relative or an unrelated perso

Phase 1

• Conditions: Children and adolecents with chronic myeloid leukemia with indication for allogeneic stem cell transplantation; MedDRA version: 20.0 Level: LLT Classification code 10009700 Term: CML System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-000569-50-AT
• Lead Sponsor: St Anna Kinderkrebsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-23
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

*Age at stem cell transplantation > 1 year and < 18 years
*Chronic myeloid leukemia (Philadelphia chromosome positive) in chronic phase
*Indication for allogeneic stem cell transplantation
*Informed consent
*Patients treated in a hospital participating in the study during the study period
*Availability of a matched sibling donor or a matched donor as defined by the study protocol

Are the trial subjects under 18? yes
Number of subjects for this age range: 160
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

*Pregnancy
*History of prior allogeneic or autologous stem cell transplantation
*Patients in blast crisis
*No informed consent

Study & Design

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