EUCTR2012-003032-22-NOActive, not recruitingPhase 1
Allogenic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia - FORUM - ALL SCT ped FORUM
St. Anna Kinderkrebsforschung GmbH0 sites1,800 target enrollmentStarted: November 25, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 1,800
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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