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Clinical Trials/EUCTR2012-003032-22-NO
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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