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

Phase 1

• Conditions: acute lymphoblastic leukaemia; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003032-22-DE
• Lead Sponsor: St. Anna Kinderkrebsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-17
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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 or age at time of HSCT less or equal 21 years
•indication for allogeneic HSCT according to the national frontline protocols (Germany: AIEOP-BFM ALL 2009, IntReALL SR 2010, Interfant 2006, CoALL and ALL REZ BFM 2002)
•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

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; severe pulmonary, hepatic or cardial impairment due to toxicity or infection)
•Karnovsky / Lansky score < 50%
•Subjects unwilling or unable to comply with the study procedures
* Severe renal impairment (GFR< 30% predicted for Age)
* Severe liver insufficiency
* Pregnancy*

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified