Allogenic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia - FORUM

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 21.0Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10066104Term: Precursor B-lymphoblastic leukaemia acuteSystem Organ Class: 100000004864; acute lymphoblastic leukaemia; MedDRA version: 21.1Level: LLTClassification code 10000848Term: Acute lymphocytic leukemiaSystem Organ Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code 10063621Term: Acute lymphoblastic leukaemia recurrentSystem Organ Class: 100000004864

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1200

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: 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; 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

Study & Design

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