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-SE

Lead Sponsor: ST.Anna Kinderkrebsforschung

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1800

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 pseudonymized 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)
•Karnovsky / 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

Primary Outcome Measures

Name	Time	Method
Main Objective: Stratum 1 – randomised question (closed in December 2018, randomised patients in active follow-up): To show that a non total body irradiation<br>(TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD).<br>Stratum 1 – MSD/MD: To explore the impact of risk factors on the incidence of adverse events of special interest (AESIs) and on overall survival and event free survival in the entire cohort (question 3 and 5).<br>Stratum 2 – MMD: To explore event free survival (EFS) after HSCT from HLA mismatched donors using mismatched unrelated donors (MMD),mismatched cord blood or HLA haplo-identical family members. ;Secondary Objective: not applicable;Primary end point(s): Stratum 1: Overall survival (OS)<br>Stratum 2: EFS<br>;Timepoint(s) of evaluation of this end point: annually

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Stratum 1: EFS<br>Stratum 2: OS<br>Stratum 1 and 2:<br>Cumulative Incidence of Treatment-related mortality (TRM)<br>Cumulative Incidence of Relapse<br>Toxicity: acute and late<br>Acute Graft versus Host Disease (aGVHD) and chronic GVHD (cGvHD)<br>Secondary malignancies;Timepoint(s) of evaluation of this end point: annually

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