very high risk acute lymphoblastic leukaemia in children and adolescents with indicaton for allogenic hematopoetic stem cell transplantation MedDRA version: 8.1 Level: LLT Classification code 10000844 Term: Acute lymphoblastic leukaemia
Conditions
Interventions
Pharmaceutical Form:
Sponsors
St. Anna Kinderkrebsforschung
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: *Age at ALL diagnosis (for HSCT indication in CR1) or at ALL relapse diagnosis: =18 years *ALL in first, second or any following complete remission *Indication for allogeneic HSCT (see chapter Indications for allogeneic HSCT, page 11) *Signed informed consent of parents or legal guardian of the minor patient (and in certain cases the patient himself/herself) for participation in the study ALL SCT BFM international. *The patient is treated in a hospital participating in the study during the study period. *No evidence of pregnancy *No secondary malignancy *No history of allogeneic or autologous HSCT All patients who are entered into the study according to these criteria are study patients. Once registered into the study, a patient is only excluded from the study, if the diagnosis ALL turns out to be clearly wrong. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: none - see above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: *To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD) *To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. *To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. *To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD. ;Secondary Objective: *To prospectively evaluate survival and event free survival after HSCT from matched sibling donors (MSD), from matched family or unrelated donors (MD) and from mismatched family or unrelated donors (MMD). *To reduce transplantation associated mortality by standardising the selection criteria for donors, the stem cell manipulation and supportive measures for allogeneic HSCT. *To prevent extensive chronic GvHD by close monitoring and by using standardised GvHD- and anti-infectious therapy. ;Primary end point(s): *event-free and overall survival after allogeneic HSCT *occurrence of acute and chronic Graft-versus-Host-Disease (GvHD) *occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT | — |
Countries
Austria, Italy
Outcome results
None listed