Allogeneic stem cell transplantation for children and adolescents with CML: Conditioning regimen, donor selection, supportive care and diagnostic procedures - CML SCT I-BFM
- Conditions
- Chronic Myeloid LeukemiaMedDRA version: 12.1Level: LLTClassification code 10009700Term: CM
- Registration Number
- EUCTR2008-000569-50-IT
- Lead Sponsor
- St. Anna Kinderkrebsforschung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Children and adolescents (age between 1 and 18 years) with bcr-abl positive CML in chronic phase, who are eligible for allogeneic stem cell transplantation, irrespective of the previous treatment strategy Availability of a matched sibling donor (MSD), a matched family donor, a matched unrelated donor or a matched unrelated cord blood (MD) Informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
Unavailability of MSD or MD Patients in accelerated phase or blast crisis Pregnancy Previous autologous or allogeneic SCT No informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of 1 year transplant related mortality of children and adolescents with CML and matched related or unrelated donors following a reduced intensity conditioning.;Secondary Objective: Evaluation of 5 year event free und current leukaemia free survival in patients undergoing frequent molecular disease monitoring with early intervention. To reduce transplant related mortality by standardizing the selection criteria for donors and the supportive measures following allogeneic stem cell transplantation To prevent extensive chronic GvHD by close monitoring and by using standardised GvHD and anti-infectious therapy;Primary end point(s): TRM Event free and current leukaemia free survival
- Secondary Outcome Measures
Name Time Method