CML-SCT -IBFM StudyAllogeneic stem cell transplantation for children and Adolescents with CML: Conditioning regimen, donor selection, supportive care and diagnostic procedures. - CML-SCT

Phase 1

• Conditions: Children and adolecents with chronic myeloid leukemia with indication for allogeneic stem cell transplantation; MedDRA version: 14.0Level: LLTClassification code 10009700Term: CMLSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-25
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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:
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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: *To reduce transplant related mortality by standardizing the selection criteria for donors and the supportive measures following allogeneic stem cell transplantation<br>*To prevent extensive chronic GvHD by close monitoring and by using standardised GvHD and anti-infectious therapy;Main Objective: *To evaluate whether transplant related mortality following allogeneic stem cell transplantation from unrelated donors for CML can be reduced by using a reduced intensity conditioning regimen<br>*To prospectively evaluate the overall survival, the event free survival and the current leukemia free survival in patients undergoing allogeneic stem cell transplantation for CML using a standardised post-transplant monitoring and early intervention;Primary end point(s): *transplant related mortality<br>*overall survival, event free survival and current leukemia free survival<br>;Timepoint(s) of evaluation of this end point: 1 year and 5 years