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

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000569-50-AT

Enrollment

160

Registered

2009-02-23

Start date

2010-01-28

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Thio-Tepa Torrex Pharmaceutical Form: INN or Proposed INN: THIOTEPA CAS Number: 52244 Trade Name: Alkeran P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Age at stem cell transplantation > 1 year and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Overall survival, Event free survival and current leukemia free survival: 5 years after SCT; Secondary end point(s): *overall survival, event free survival and current leukemia free survival	—

Primary

Measure	Time frame
Primary end point(s): transplant related mortality overall survival, event free survival and current leukemia free survival ; Timepoint(s) of evaluation of this end point: for transplant related mortality: one year after SCT ; 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 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 ; Secondary Objective: 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	—

Measure

Time frame

Primary end point(s): *transplant related mortality *overall survival, event free survival and current leukemia free survival ; Timepoint(s) of evaluation of this end point: for transplant related mortality: one year after SCT ; 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 *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 ; Secondary Objective: *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

—

Countries

Austria, Czech Republic, Italy

Contacts

Public ContactS2IRP - CML SCT study centre

St. Anna Kinderkrebsforschung

susanne.matthes@stanna.at004301401704980

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026