Allogenic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia - FORUM (For Omitting Radiotherapy Under Majority age) - ALL SCT ped FORUM

St. Anna Kinderkrebsforschung0 sites1,000 target enrollmentStarted: November 22, 2017Last updated: February 19, 2018

Conditions

Drugs

Trial Snapshot

No summary available.

•All patients with ALL (except for patients with 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: 1000
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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 cardial impairment due to toxicity or infection
•Karnofsky / Lansky score < 50%
•Subjects unwilling or unable to comply with the study procedures

Sponsor