acute lymphoblastic leukaemia
Conditions
Sponsors
St. Anna Kinderkrebsforschung GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • All patients with ALL (except for patients with mature B-ALL) who fulfil the following criteria: • age at time of diagnosis less or equal 18 years; at time of HSCT less or equal 21 years • indication for allogeneic HSCT • complete remission (CR) before SCT • written consent of the parents (legal guardian) and, if necessary, the minor patient via “Informed Consent Form” • no pregnancy • no secondary malignancy • no previous HSCT • HSCT is performed in a study participating centre Are the trial subjects under 18? yes Number of subjects for this age range: 1800 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who do not fulfil the inclusion criteria • Non Hodgkin-Lymphoma • The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian • No consent is given for saving and propagation of anonymous medical data for study reasons • Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion: e.g. malformation syndromes, cardiac malformations, metabolic disorders; Renal impairment (< 30% of normal glomerular filtration rate), Severe pulmonary, hepatic or cardiac impairment due to toxicity or infection. • Karnofsky / Lansky score < 50% • Subjects unwilling or unable to comply with the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Stratum 1 – randomised question (closed in December 2018, randomised patients in active follow-up): To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD). Stratum 1 – MSD/MD: To explore the impact of risk factors on the incidence of adverse events of special interest (AESIs) and on overall survival and event free survival in the entire cohort (question 3 and 5). Stratum 2 – MMD: To explore event free survival (EFS) after HSCT from HLA mismatched donors using mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family members. ;Secondary Objective: not applicable;Primary end point(s): Stratum 1: Overall Survival (OS) Stratum 2: EFS ;Timepoint(s) of evaluation of this end point: annually | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Stratum 1: EFS Stratum 2: OS Stratum 1 and 2: Cumulative Incidence of Treatment-related mortality (TRM) Cumulative Incidence of Relapse Toxicity: acute and late Acute Graft versus Host Disease (aGVHD) and chronic GVHD (cGvHD) Secondary malignancies ;Timepoint(s) of evaluation of this end point: annually | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, Croatia, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey
Contacts
Public ContactInternational Study Chair
St. Anna Kinderkrebsforschung GmbH
Outcome results
None listed